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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Cardiac, External
510(k) Number K972525
Device Name THUMPER
Applicant
Michigan Instruments, Inc.
4717 Talon Ct., SE
Grand Rapids,  MI  49512
Applicant Contact JAMES D MAATMAN
Correspondent
Michigan Instruments, Inc.
4717 Talon Ct., SE
Grand Rapids,  MI  49512
Correspondent Contact JAMES D MAATMAN
Regulation Number870.5200
Classification Product Code
DRM  
Date Received07/07/1997
Decision Date 10/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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