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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,Nonresorbable For External Use
510(k) Number K914842
Device Name GAUZE BANDAGE ROLL
Applicant
Cal West Trading Co.
9915 Bell Ranch Dr.
Santa Fe Springs,  CA  90670
Applicant Contact ANDY CHAO
Correspondent
Cal West Trading Co.
9915 Bell Ranch Dr.
Santa Fe Springs,  CA  90670
Correspondent Contact ANDY CHAO
Regulation Number878.4014
Classification Product Code
NAB  
Date Received10/28/1991
Decision Date 12/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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