FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHARPOINT STAINLESS STEEL SUTURE
K Number: K863034
·
Decision Sep 30, 1986
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
3
Applicant Total
4
Review Days
50
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Basic Information
- Device Name
- SHARPOINT STAINLESS STEEL SUTURE
- K Number
- K863034
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4495
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Chathamborough Research Group, Inc.
- Date Received
- August 11, 1986
- Decision Date
- September 30, 1986
- Product Code
- GAO
- 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 |
|---|---|---|---|
| GAO | Suture, Nonabsorbable | FDA class 2 | General, Plastic Surgery |
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