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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 K920620
Device Name FLUORO-SHIELD RADIATION REDUCTION GLOVES
Applicant
Acufex Microsurgical, Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact IVAN S PLACKO
Correspondent
Acufex Microsurgical, Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact IVAN S PLACKO
Regulation Number880.6250
Classification Product Code
LZC  
Date Received02/11/1992
Decision Date 06/22/1993
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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