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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 K882437
Device Name L3 (LEAD LATEX LYSNIG GLOVES)
Applicant
The Branford Co.
Post Office Box 713
Shelton,  CT  06484
Applicant Contact KENNETH W KUBOFCIK
Correspondent
The Branford Co.
Post Office Box 713
Shelton,  CT  06484
Correspondent Contact KENNETH W KUBOFCIK
Regulation Number880.6250
Classification Product Code
LZC  
Date Received06/14/1988
Decision Date 05/11/1989
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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