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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Restraint, Protective
510(k) Number K963458
Device Name PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS
Applicant
Skil-Care Corp.
167 Saw Mill River Rd.
Yonkers,  NY  10701
Applicant Contact ARNOLD SILVERMAN
Correspondent
Skil-Care Corp.
167 Saw Mill River Rd.
Yonkers,  NY  10701
Correspondent Contact ARNOLD SILVERMAN
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received09/03/1996
Decision Date 10/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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