The following data is part of a premarket notification filed by Class A Ent. with the FDA for Disposable Monopolar Needle Electrode.
| Device ID | K912783 |
| 510k Number | K912783 |
| Device Name: | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE |
| Classification | Electrode, Needle |
| Applicant | CLASS A ENT. 7607 LUCERNE VISTA Yucca Valley, CA 92284 |
| Contact | Janice A.audi |
| Correspondent | Janice A.audi CLASS A ENT. 7607 LUCERNE VISTA Yucca Valley, CA 92284 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-24 |
| Decision Date | 1992-02-05 |