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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Barrier, Protective
510(k) Number K952241
Device Name PROTOUCH OVERGLOVE
Applicant
Cottrell, Ltd.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact FRANK S CASCIANI
Correspondent
Cottrell, Ltd.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact FRANK S CASCIANI
Regulation Number878.4370
Classification Product Code
MMP  
Date Received05/12/1995
Decision Date 08/07/1995
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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