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510(k) K951352

DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE by Davis & Geck, Inc. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1995
Date Received
March 24, 1995
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 Davis & Geck, Inc.

  • K982853 — SILK SUTURE (April 30, 1999)
  • K981582 — SURGILON, DERMALON, & OPHTHALON (July 13, 1998)
  • K980610 — DEXON RAPID (DEXON R) (May 18, 1998)
  • K974015 — ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QU (May 18, 1998)
  • K980062 — MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE (March 20, 1998)
  • K973409 — KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS (February 27, 1998)
  • K970857 — ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL AR (November 5, 1997)
  • K972139 — ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOP (September 3, 1997)
  • K972566 — DEXON VIOLET (August 14, 1997)
  • K962971 — POLYPROPYLENE MESH (VARIOUS SIZES) (September 16, 1996)

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