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 |