FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
REXLON, REXSIL
K Number: K161633
·
Decision Mar 2, 2017
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
56
Applicant Total
5
Review Days
262
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Basic Information
- Device Name
- REXLON, REXSIL
- K Number
- K161633
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sm Eng Co., Ltd.
- Date Received
- June 13, 2016
- Decision Date
- March 2, 2017
- Product Code
- GAR
- 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 |
|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | FDA class 2 | General, Plastic Surgery |
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