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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K101350
Device Name RADSCAN EQUIPMENT SLICKER
Applicant
Radscan Medical Equipment, Inc.
23910 N. 19th Ave. Bldg. 2 Suite
Phoenix,  AZ  85085
Applicant Contact ORAN R BROWN
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Regulation Number878.4370
Classification Product Code
KKX  
Date Received05/14/2010
Decision Date 01/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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