FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
R PAK
K Number: K851203
·
Decision Jul 23, 1985
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
97
Review Days
119
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Basic Information
- Device Name
- R PAK
- K Number
- K851203
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- CooperVision, Inc.
- Date Received
- March 26, 1985
- Decision Date
- July 23, 1985
- Product Code
- LFL
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFL), ordered by most recent decision date.
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SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)
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Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
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Tenex 2nd Generation System
FDA 510(k)
FDA Unclassified
·Unknown
CUSA® Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
Ultrasonic Surgical System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by CooperVision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | Jan 25, 2024 | Substantially Equivalent |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens | Feb 4, 2022 | Substantially Equivalent |
| K213164 | Avaira Vitality | Oct 26, 2021 | Substantially Equivalent |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) | Oct 20, 2020 | Substantially Equivalent |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC | Mar 23, 2020 | Substantially Equivalent |
| K190965 | MyDay | Apr 29, 2019 | Substantially Equivalent |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | Dec 11, 2018 | Substantially Equivalent |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | Jul 13, 2016 | Substantially Equivalent |
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | Dec 23, 2013 | Substantially Equivalent |
| K131378 | SUS (STENFILCON A) CONTACT LENS | Aug 30, 2013 | Substantially Equivalent |