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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Sponge, Surgical
510(k) Number K093557
Device Name SMARTWAND-DTX
Applicant
CLEARCOUNT MEDICAL SOLUTIONS
101 BELLEVUE RD., SUITE 300
PITTSBURGH,  PA  15229
Applicant Contact JEFF WOLFGONG
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.2740
Classification Product Code
LWH  
Date Received11/16/2009
Decision Date 12/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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