The following data is part of a premarket notification filed by Pfizer Hospital Products Group, Inc. with the FDA for Bondek Polyglycolic Acid Synthetic Absorb. Suture.
| Device ID | K905482 |
| 510k Number | K905482 |
| Device Name: | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | PFIZER HOSPITAL PRODUCTS GROUP, INC. 600 AIRPORT RD. Fall River, MA 02722 |
| Contact | Michael Santalucia |
| Correspondent | Michael Santalucia PFIZER HOSPITAL PRODUCTS GROUP, INC. 600 AIRPORT RD. Fall River, MA 02722 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-06 |
| Decision Date | 1991-03-14 |