FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
REXMONO, PDREX
K Number: K173779
·
Decision Mar 12, 2018
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
147
Applicant Total
5
Review Days
90
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Basic Information
- Device Name
- REXMONO, PDREX
- K Number
- K173779
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sm Eng Co., Ltd.
- Date Received
- December 12, 2017
- Decision Date
- March 12, 2018
- Product Code
- GAM
- 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 |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | FDA class 2 | General, Plastic Surgery |
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