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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 K894828
Device Name HPI ORTHO SURGEONS' GLOVE
Applicant
TILLOTSON RUBBER CO., INC.
825 BEACON ST.
SUITE 11
NEWTON CENTRE,  MA  02159
Applicant Contact IMOGENE TIBBETTS
Correspondent
TILLOTSON RUBBER CO., INC.
825 BEACON ST.
SUITE 11
NEWTON CENTRE,  MA  02159
Correspondent Contact IMOGENE TIBBETTS
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/31/1989
Decision Date 05/07/1990
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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