FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MCSC6PS MEDICAL COMPONENTS
K Number: K821820
·
Decision Jul 13, 1982
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
63
Review Days
22
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Basic Information
- Device Name
- MCSC6PS MEDICAL COMPONENTS
- K Number
- K821820
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Medical Components, Inc.
- Date Received
- June 21, 1982
- Decision Date
- July 13, 1982
- 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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FDA Unclassified
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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
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| K123617 | 3F PRO-PICC | May 15, 2013 | Substantially Equivalent |
| K122423 | VASU-PICC | Dec 12, 2012 | Substantially Equivalent |
| K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM | Sep 21, 2012 | Unknown |