The following data is part of a premarket notification filed by Electronic Waveform Laboratory, Inc. with the FDA for E.w.l. P-tens/h-wave For General Dentistry.
| Device ID | K873604 |
| 510k Number | K873604 |
| Device Name: | E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY |
| Classification | Device, Electrical Dental Anesthesia |
| Applicant | ELECTRONIC WAVEFORM LABORATORY, INC. 15683 CHEMICAL LN. Huntington Beach, CA 92649 |
| Contact | William J Heaney |
| Correspondent | William J Heaney ELECTRONIC WAVEFORM LABORATORY, INC. 15683 CHEMICAL LN. Huntington Beach, CA 92649 |
| Product Code | LWM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-04 |
| Decision Date | 1988-04-12 |