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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K842268
Device Name VACUPULSE VACUUM UNIT
Applicant
I-REP, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
I-REP, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number890.5850
Classification Product Code
IPF  
Date Received06/08/1984
Decision Date 07/20/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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