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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K111313
Device Name EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE
Applicant
Alcavis Hdc, LLC
8322 Helgerman Ct.
Gaithersburg,  MD  20877
Applicant Contact GARY J MISHKIN
Correspondent
Alcavis Hdc, LLC
8322 Helgerman Ct.
Gaithersburg,  MD  20877
Correspondent Contact GARY J MISHKIN
Regulation Number880.5475
Classification Product Code
FQH  
Date Received05/10/2011
Decision Date 12/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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