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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 K890434
Device Name EMS 300 MUSCLE STIMULATORS
Applicant
PARANAMICS, INC.
1865 SUMMIT DR.
SUITE 600
PLANO,  TX  75074
Applicant Contact JOHN OBER
Correspondent
PARANAMICS, INC.
1865 SUMMIT DR.
SUITE 600
PLANO,  TX  75074
Correspondent Contact JOHN OBER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received01/27/1989
Decision Date 10/17/1989
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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