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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
510(k) Number K912955
Device Name EYE PAD
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
Classification Product Code
EFQ  
Date Received07/02/1991
Decision Date 09/10/1991
Decision Substantially Equivalent (SESE)
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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