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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 K874539
Device Name HI-TOUCH (TM) BRAND SURGICAL GLOVES
Applicant
Apex Medical Technologies, Inc.
10064 Mesa Ridge Ct., #202
San Diego,  CA  92121
Applicant Contact ALICE A DEPAUL
Correspondent
Apex Medical Technologies, Inc.
10064 Mesa Ridge Ct., #202
San Diego,  CA  92121
Correspondent Contact ALICE A DEPAUL
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/03/1987
Decision Date 12/14/1987
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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