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510(k) K061467

EXSEPT WC WOUND CLEANSER by Alcavis International, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2007
Date Received
May 26, 2006
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 Alcavis International, Inc.

  • K082858 — EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER (May 27, 2009)
  • K043126 — ASSIST HEADER CLEANER (February 3, 2005)

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