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 |