The following data is part of a premarket notification filed by Bauer Medical, Inc. with the FDA for Temno Double Shot Biopsy Needle.
| Device ID | K960065 |
| 510k Number | K960065 |
| Device Name: | TEMNO DOUBLE SHOT BIOPSY NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | BAUER MEDICAL, INC. 13191 56TH COURT SUITE 106 Clearwater, FL 34620 |
| Contact | Pat Lamb |
| Correspondent | Pat Lamb BAUER MEDICAL, INC. 13191 56TH COURT SUITE 106 Clearwater, FL 34620 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-05 |
| Decision Date | 1996-04-05 |