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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K951911
Device Name GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)
Applicant
Commercial Resources New Mexico, Ltd.
1900 S. Telshor Blve.
Suite A
Las Cruces,  NM  88011
Applicant Contact M. J HIGA
Correspondent
Commercial Resources New Mexico, Ltd.
1900 S. Telshor Blve.
Suite A
Las Cruces,  NM  88011
Correspondent Contact M. J HIGA
Regulation Number878.4450
Classification Product Code
GDY  
Date Received04/24/1995
Decision Date 06/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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