FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERRALAPG
K Number: K033762
·
Decision Mar 15, 2004
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
147
Applicant Total
6
Review Days
104
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Basic Information
- Device Name
- SERRALAPG
- K Number
- K033762
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Serral, S.A. DE C.V.
- Date Received
- December 2, 2003
- Decision Date
- March 15, 2004
- 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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Other Clearances by Serral, S.A. DE C.V.
| K Number | Device Name | ||
|---|---|---|---|
| K020597 | SERRALGUT | Aug 14, 2002 | Substantially Equivalent |
| K020902 | SERRALESTER | May 20, 2002 | Substantially Equivalent |
| K020901 | SERRALSILK | Apr 26, 2002 | Substantially Equivalent |
| K020146 | SERRALNYL | Apr 15, 2002 | Substantially Equivalent |
| K020265 | SERRALENE, MODEL CATALOG NO 1S | Mar 8, 2002 | Substantially Equivalent |