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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K022719
Device Name PHYSICAL MONITORING REGISTRATION UNIT
Applicant
MARYROSE CUSIMANO, PH.D./PHIL REASTON
5367 NW 90TH AVE.
SUNRISE,  FL  33319
Applicant Contact MARYROSE CUSIMANO
Correspondent
MARYROSE CUSIMANO, PH.D./PHIL REASTON
5367 NW 90TH AVE.
SUNRISE,  FL  33319
Correspondent Contact MARYROSE CUSIMANO
Regulation Number890.1375
Classification Product Code
IKN  
Date Received08/15/2002
Decision Date 11/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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