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510(k) K111313

EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE by Alcavis Hdc, LLC — Product Code FQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2011
Date Received
May 10, 2011
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

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