FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE
K Number: K905482
·
Decision Mar 14, 1991
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
147
Applicant Total
8
Review Days
98
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Basic Information
- Device Name
- BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE
- K Number
- K905482
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Pfizer Hospital Products Group, Inc.
- Date Received
- December 6, 1990
- Decision Date
- March 14, 1991
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K930156 | MEGA PLUS SUPER LAG SCREW | Feb 22, 1994 | Substantially Equivalent |
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| K920831 | PCA TOTAL HIP SYSTEM (CEMENTLESS USE) | Jun 10, 1992 | Substantially Equivalent |
| K920034 | DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC | Mar 18, 1992 | Substantially Equivalent |
| K915184 | HOWMEDICA ALUMINA FEMORAL HEAD | Jan 31, 1992 | Substantially Equivalent |
| K911656 | PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST | Aug 13, 1991 | Substantially Equivalent |
| K911292 | SCHNEIDER WALLSTENT(R) | May 1, 1991 | Substantially Equivalent |