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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring (Wound Protector), Drape Retention, Internal
510(k) Number K113268
Device Name ALEXIS O WOUND PROTECTOR/RETRACTOR
Applicant
APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact FRANS VANDENBROEK
Correspondent
APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact FRANS VANDENBROEK
Regulation Number878.4370
Classification Product Code
KGW  
Date Received11/04/2011
Decision Date 02/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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