FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GOLNIT Non-Absorbable PTFE Surgical Suture
K Number: K163049
·
Decision Jun 21, 2017
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
16
Applicant Total
1
Review Days
232
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Basic Information
- Device Name
- GOLNIT Non-Absorbable PTFE Surgical Suture
- K Number
- K163049
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5035
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Antarma Dba Golnit Sutures
- Date Received
- November 1, 2016
- Decision Date
- June 21, 2017
- Product Code
- NBY
- 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 |
|---|---|---|---|
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | FDA class 2 | General, Plastic Surgery |
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