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510(k) K011941

EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 by The Kendall Company — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2001
Date Received
June 21, 2001
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

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  • K042572 — KENDALL CO2NFIRM NOW CO2 DETECTOR (November 5, 2004)
  • K041914 — PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER (September 27, 2004)

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