The following data is part of a premarket notification filed by Bauer Medical, Inc. with the FDA for Bauer Temno Coaxial Needle.
| Device ID | K935538 |
| 510k Number | K935538 |
| Device Name: | BAUER TEMNO COAXIAL NEEDLE |
| Classification | Guide, Needle, Surgical |
| Applicant | BAUER MEDICAL, INC. P.O. BOX 2010 Palm Harbor, FL 34682 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb BAUER MEDICAL, INC. P.O. BOX 2010 Palm Harbor, FL 34682 |
| Product Code | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-16 |
| Decision Date | 1994-02-22 |