FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SILKAM NONABSORBABLE SILK SURGICAL SUTURE
K Number: K990089
·
Decision Mar 15, 1999
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
40
Applicant Total
207
Review Days
63
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Basic Information
- Device Name
- SILKAM NONABSORBABLE SILK SURGICAL SUTURE
- K Number
- K990089
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5030
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap, Inc.
- Date Received
- January 11, 1999
- Decision Date
- March 15, 1999
- Product Code
- GAP
- 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 |
|---|---|---|---|
| GAP | Suture, Nonabsorbable, Silk | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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