FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
K Number: K143582
·
Decision Oct 29, 2015
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
84
Applicant Total
4
Review Days
315
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Basic Information
- Device Name
- MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
- K Number
- K143582
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Resorba Medical GmbH
- Date Received
- December 18, 2014
- Decision Date
- October 29, 2015
- Product Code
- GAW
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | FDA class 2 | General, Plastic Surgery |
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