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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K891951
Device Name THREE GUN PATIENT EXAMINATION GLOVES
Applicant
Bilwin Corp.
1123, Broadway
Suite 308
New York,  NY  10010
Applicant Contact WILLIAM LEE
Correspondent
Bilwin Corp.
1123, Broadway
Suite 308
New York,  NY  10010
Correspondent Contact WILLIAM LEE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/28/1989
Decision Date 07/14/1989
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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