The following data is part of a premarket notification filed by Medelec, Inc. D.b.a. Teca Corp. with the FDA for Teca Myoject Disposable Needle Electrodes.
| Device ID | K973444 |
| 510k Number | K973444 |
| Device Name: | TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | MEDELEC, INC. D.B.A. TECA CORP. 3 CAMPUS DR. Pleasantville, NY 10570 |
| Contact | James P Hurlman |
| Correspondent | James P Hurlman MEDELEC, INC. D.B.A. TECA CORP. 3 CAMPUS DR. Pleasantville, NY 10570 |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-11 |
| Decision Date | 1997-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830033381 | K973444 | 000 |
| 00382830028752 | K973444 | 000 |
| 00382830028745 | K973444 | 000 |
| 00382830028738 | K973444 | 000 |
| 00382830028721 | K973444 | 000 |
| 00382830028714 | K973444 | 000 |
| 00382830028707 | K973444 | 000 |