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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K883466
Device Name STERILE SURGICAL GLOVES
Applicant
CAL-AMERICAN EXPORTS, INC.
2651 MANHATTAN BEACH BLVD.
REDONDO BEACH,  CA  90278
Applicant Contact WALLACE WONG
Correspondent
CAL-AMERICAN EXPORTS, INC.
2651 MANHATTAN BEACH BLVD.
REDONDO BEACH,  CA  90278
Correspondent Contact WALLACE WONG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/15/1988
Decision Date 11/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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