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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 K100120
Device Name ALEXIS ORTHOPAEDIC WOUND 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 Received01/15/2010
Decision Date 04/02/2010
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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