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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 Dr. 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
Predetermined Change
Control Plan Authorized		 No
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