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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drape, surgical
510(k) Number K113268
Device Name ALEXIS O WOUND PROTECTOR/RETRACTOR
Original Applicant
APPLIED MEDICAL RESOURCES CORP.
22872 avenida empresa
rancho santa margarita,  CA  92688
Original Contact frans vandenbroek
Regulation Number878.4370
Classification Product Code
KKX  
Date Received11/04/2011
Decision Date 02/08/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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