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510(k) K012957

TOWEL DRAPE, MODELS 4409, 4410 by Dynarex Corp. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2002
Date Received
September 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Dynarex Corp.

  • K052743 — DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 (December 22, 2005)
  • K052314 — DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE (November 9, 2005)
  • K012816 — DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 (October 17, 2002)
  • K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B (November 28, 2001)
  • K991694 — DYNAREX DRAIN SPONGE (July 15, 1999)
  • K991695 — DYNAREX NON-WOVEN SPONGE (July 15, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K960388 — DYNAREX NON-WOVEN SPONGE (April 1, 1996)
  • K951660 — DYNAREX GAUZE SPONGE (May 9, 1995)
  • K933308 — DYNAREX GAUZE SPONGE OR PADS (December 22, 1993)

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