The following data is part of a premarket notification filed by Neward Enterprises, Inc. with the FDA for Cr Spiral Electrode.
| Device ID | K910815 |
| 510k Number | K910815 |
| Device Name: | CR SPIRAL ELECTRODE |
| Classification | Electrode, Circular (spiral), Scalp And Applicator |
| Applicant | NEWARD ENTERPRISES, INC. P.O. BOX 725 9251 ARCHIBALD AVENUE Cucamonga, CA 91730 |
| Contact | Allyson C Carmack |
| Correspondent | Allyson C Carmack NEWARD ENTERPRISES, INC. P.O. BOX 725 9251 ARCHIBALD AVENUE Cucamonga, CA 91730 |
| Product Code | HGP |
| CFR Regulation Number | 884.2675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-26 |
| Decision Date | 1991-12-10 |