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510(k) K070685

KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 by Tyco Healthcare — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2007
Date Received
March 12, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Tyco Healthcare

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  • K061492 — MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE (August 3, 2006)
  • K042709 — DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER (January 18, 2005)
  • K040897 — DOVER ROB-NEL CATHETER (July 20, 2004)
  • K040649 — KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE (July 15, 2004)
  • K041243 — DOVER RED RUBBER ROBINSON CATHETER (July 7, 2004)
  • K032438 — MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PRE (June 30, 2004)
  • K033453 — KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING (April 29, 2004)
  • K032827 — KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (December 8, 2003)

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