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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Muscle Monitoring
510(k) Number K862121
Device Name E.W.L. P-TENS/H-WAVE
Applicant
Electronic Waveform Laboratory, Inc.
15683 Chemical Ln.
Huntington Beach,  CA  92649
Applicant Contact W. J HEANEY
Correspondent
Electronic Waveform Laboratory, Inc.
15683 Chemical Ln.
Huntington Beach,  CA  92649
Correspondent Contact W. J HEANEY
Regulation Number890.1375
Classification Product Code
KZM  
Date Received06/03/1986
Decision Date 06/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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