FDA 510(k) Applications Submitted by GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

FDA 510(k) Number Submission Date Device Name Applicant
K981322 04/10/1998 CUTALON NYLON POLYAMIDE SURGICAL SUTURE GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
K991191 04/08/1999 BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
K001434 05/08/2000 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
K001440 05/08/2000 NEXTSTITCH CARDIOVASCULAR VALVE SUTURE GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
K992088 06/21/1999 BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
K991416 04/23/1999 ENDOSCOPIC CAMERA GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
K980016 01/02/1998 MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
K990062 01/08/1999 SAPHLIFT GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
K982712 08/04/1998 RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)


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