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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cream, Gloving, Surgeon'S
510(k) Number K910687
Device Name GUARDIAN GEL, SURGEON'S GLOVING CREAM
Applicant
Guardian Angel Products, Inc.
Columbia Sq.
555 Thirteeth St. NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Guardian Angel Products, Inc.
Columbia Sq.
555 Thirteeth St. NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number878.4470
Classification Product Code
KGQ  
Date Received02/19/1991
Decision Date 10/11/1991
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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