FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PDS PLATES
K Number: K092590
·
Decision Feb 17, 2010
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
13
Applicant Total
172
Review Days
177
Basic Information
- Device Name
- PDS PLATES
- K Number
- K092590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ETHICON, INC.
- Date Received
- August 24, 2009
- Decision Date
- February 17, 2010
- Product Code
- NHB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
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PuraSinus
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Latera Absorbable Nasal Implant
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FDA Class 2
·Ear, Nose, Throat
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| K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | Dec 6, 2013 | Substantially Equivalent |