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510(k) K082858

EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER by Alcavis International, Inc. — Product Code FQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2009
Date Received
September 29, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type

Other clearances by Alcavis International, Inc.

  • K061467 — EXSEPT WC WOUND CLEANSER (February 15, 2007)
  • K043126 — ASSIST HEADER CLEANER (February 3, 2005)

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