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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiographic Protective Glove
510(k) Number K904878
Device Name SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
Applicant
Hpi, Inc.
825 Beacon St.
Suite 11
Newton Centre,  MA  02159
Applicant Contact JUDITH A GENZALE
Correspondent
Hpi, Inc.
825 Beacon St.
Suite 11
Newton Centre,  MA  02159
Correspondent Contact JUDITH A GENZALE
Regulation Number892.6500
Classification Product Code
IWP  
Date Received10/30/1990
Decision Date 03/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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