FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
K Number: K063603
·
Decision Feb 7, 2007
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
31
Applicant Total
4
Review Days
66
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Basic Information
- Device Name
- SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
- K Number
- K063603
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.4495
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Suturtek Incorporated
- Date Received
- December 3, 2006
- Decision Date
- February 7, 2007
- Product Code
- GAQ
- 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 |
|---|---|---|---|
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | FDA class 2 | General, Plastic Surgery |
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