EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE


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

Correspodent Contact gary j mishkin
Regulation Number 880.5475
Classification Product Code
FQH  
Date Received 05/10/2011
Decision Date 12/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes