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510(k) K980610

DEXON RAPID (DEXON R) by Davis & Geck, Inc. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1998
Date Received
February 17, 1998
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)
  • 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)
  • K955722 — FLEXON TEMPORARY CARDIAC PACER LEAD (March 15, 1996)

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