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510(k) K991191

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE by Genzyme Surgical Product (Genzyme Biosurgery) — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1999
Date Received
April 8, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

Other clearances by Genzyme Surgical Product (Genzyme Biosurgery)

  • K001440 — NEXTSTITCH CARDIOVASCULAR VALVE SUTURE (November 13, 2000)
  • K001434 — 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGIC (June 12, 2000)
  • K992088 — BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE (September 3, 1999)
  • K991416 — ENDOSCOPIC CAMERA (July 20, 1999)
  • K990062 — SAPHLIFT (March 30, 1999)
  • K982712 — RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 (December 18, 1998)
  • K980016 — MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE (August 7, 1998)
  • K981322 — CUTALON NYLON POLYAMIDE SURGICAL SUTURE (July 7, 1998)

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