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 |
|
Date Received | 09/04/1987 |
Decision Date | 04/12/1988 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|