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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 K062907
FOIA Releasable 510(k) K062907
Device Name ALEXIS WOUND RETRACTOR
Applicant
APPLIED MEDICAL RESOURCES
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact CHERYL BLAKE
Correspondent
APPLIED MEDICAL RESOURCES
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact CHERYL BLAKE
Regulation Number878.4370
Classification Product Code
KGW  
Subsequent Product Code
KNA  
Date Received09/27/2006
Decision Date 01/09/2007
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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