The following data is part of a premarket notification filed by Genzyme Surgical Product (genzyme Biosurgery) with the FDA for Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture.
| Device ID | K991191 |
| 510k Number | K991191 |
| Device Name: | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Contact | Mary E Gray |
| Correspondent | Mary E Gray GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-08 |
| Decision Date | 1999-06-22 |
| Summary: | summary |