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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 K910383
Device Name HPI SENSI-SHIELD GLOVE KIT
Applicant
Hpi, Inc.
64 Myrtle St.
West Newton,  MA  02165
Applicant Contact IMOGENE TIBBETS
Correspondent
Hpi, Inc.
64 Myrtle St.
West Newton,  MA  02165
Correspondent Contact IMOGENE TIBBETS
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/30/1991
Decision Date 03/20/1991
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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