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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 K971381
Device Name POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES
Applicant
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK,  IL  60085
Applicant Contact MARYALICE SMITH
Correspondent
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK,  IL  60085
Correspondent Contact MARYALICE SMITH
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/14/1997
Decision Date 07/09/1997
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
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