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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 K902371
Device Name HAELAN 340 MUSCLE STIMULATOR
Applicant
Paranamics, Inc.
One Memory Ln.
Garrettsville,  OH  44231
Applicant Contact JOHN OBER
Correspondent
Paranamics, Inc.
One Memory Ln.
Garrettsville,  OH  44231
Correspondent Contact JOHN OBER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/29/1990
Decision Date 09/12/1990
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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