FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
REXSIN
K Number: K200392
·
Decision Jul 7, 2020
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
147
Applicant Total
5
Review Days
140
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Basic Information
- Device Name
- REXSIN
- K Number
- K200392
- 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
- February 18, 2020
- Decision Date
- July 7, 2020
- 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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