The following data is part of a premarket notification filed by Genzyme Surgical Product (genzyme Biosurgery) with the FDA for Cutalon Nylon Polyamide Surgical Suture.
| Device ID | K981322 |
| 510k Number | K981322 |
| Device Name: | CUTALON NYLON POLYAMIDE SURGICAL SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Contact | Jim Kenney |
| Correspondent | Jim Kenney GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-10 |
| Decision Date | 1998-07-07 |
| Summary: | summary |