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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 K952303
Device Name SPLASH ASSIST
Applicant
Innovative Outsourcing Solutions
51 Middlesex St.
N. Chelmsford,  MA  01863
Applicant Contact GERALD S ABERNATHY
Correspondent
Innovative Outsourcing Solutions
51 Middlesex St.
N. Chelmsford,  MA  01863
Correspondent Contact GERALD S ABERNATHY
Regulation Number878.4040
Classification Product Code
LYU  
Date Received05/16/1995
Decision Date 08/24/1995
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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