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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K972663
Device Name SMART SET
Applicant
Top Spins, Inc.
1642 Gloucester
Plymouth,  MI  48170
Applicant Contact MARTIN R PRINCE
Correspondent
Top Spins, Inc.
1642 Gloucester
Plymouth,  MI  48170
Correspondent Contact MARTIN R PRINCE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/08/1997
Decision Date 09/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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