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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tourniquet, Pneumatic
510(k) Number K071140
Device Name MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002
Applicant
Top Spins, Inc.
403 Riverview Dr.
Ann Arbor,  MI  48107
Applicant Contact ERIN BUETHE
Correspondent
Top Spins, Inc.
403 Riverview Dr.
Ann Arbor,  MI  48107
Correspondent Contact ERIN BUETHE
Regulation Number878.5910
Classification Product Code
KCY  
Date Received04/24/2007
Decision Date 06/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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