FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUTRASILK SILK SUTURE
K Number: K994177
·
Decision Feb 8, 2000
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
40
Applicant Total
4
Review Days
60
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Basic Information
- Device Name
- SUTRASILK SILK SUTURE
- K Number
- K994177
- 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
- Visionary Medical Supplies, Inc.
- Date Received
- December 10, 1999
- Decision Date
- February 8, 2000
- 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 |
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