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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K935723
Device Name SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD)
Applicant
Cabot Safety Corp.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY M MCNAMARA
Correspondent
Cabot Safety Corp.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY M MCNAMARA
Regulation Number878.4040
Classification Product Code
LYU  
Date Received11/24/1993
Decision Date 04/06/1994
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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