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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 K875349
Device Name STERILE SURGICAL NATURAL LATEX GLOVES
Applicant
MARAND PRODUCTS, INC.
P.O. BOX 727
DEER PARK,  NY  11729
Applicant Contact ANDERS HEIDEMANN
Correspondent
MARAND PRODUCTS, INC.
P.O. BOX 727
DEER PARK,  NY  11729
Correspondent Contact ANDERS HEIDEMANN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received12/31/1987
Decision Date 02/16/1988
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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