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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, Electrical Dental Anesthesia
510(k) Number K873604
Device Name E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY
Applicant
ELECTRONIC WAVEFORM LABORATORY, INC.
15683 CHEMICAL LN.
HUNTINGTON BEACH,  CA  92649
Applicant Contact WILLIAM J HEANEY
Correspondent
ELECTRONIC WAVEFORM LABORATORY, INC.
15683 CHEMICAL LN.
HUNTINGTON BEACH,  CA  92649
Correspondent Contact WILLIAM J HEANEY
Classification Product Code
LWM  
Date Received09/04/1987
Decision Date 04/12/1988
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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