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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 K002104
Device Name COMBINED PHYSIOLOGICAL MONITORING SYSTEM
Applicant
Maryrose Cusimano, Ph.D. & Scott Zeff
7481 W. Oakland Park Blvd.
# 305
Ft. Lauderdale,  FL  33319
Applicant Contact MARYROSE CUSIMANO
Correspondent
Maryrose Cusimano, Ph.D. & Scott Zeff
7481 W. Oakland Park Blvd.
# 305
Ft. Lauderdale,  FL  33319
Correspondent Contact MARYROSE CUSIMANO
Regulation Number890.1375
Classification Product Code
IKN  
Date Received07/12/2000
Decision Date 10/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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