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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K953712
Device Name DERRICK SURESHIELD
Applicant
M.P.S. Pharm'L Int'L
7542 N. Oakley
Chicago,  IL  60645
Applicant Contact MAYNARD SANCHEZ
Correspondent
M.P.S. Pharm'L Int'L
7542 N. Oakley
Chicago,  IL  60645
Correspondent Contact MAYNARD SANCHEZ
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/09/1995
Decision Date 10/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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