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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K891968
Device Name ESP RADIATION REDUCTION EXAMINATION GLOVES
Applicant
Boston Scientific Corp
480 Pleasant St.
P.O. Box 7407
Watertown,  MA  02272
Applicant Contact ALBERT SEPRINSKI
Correspondent
Boston Scientific Corp
480 Pleasant St.
P.O. Box 7407
Watertown,  MA  02272
Correspondent Contact ALBERT SEPRINSKI
Regulation Number880.6250
Classification Product Code
LZC  
Date Received03/29/1989
Decision Date 05/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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