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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 K974356
Device Name SURGEON'S GLOVES
Applicant
American Health Products, Inc.
528 Amapola Ave.
Torrance,  CA  90501
Applicant Contact TONY K DJIE
Correspondent
American Health Products, Inc.
528 Amapola Ave.
Torrance,  CA  90501
Correspondent Contact TONY K DJIE
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/19/1997
Decision Date 01/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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