The following data is part of a premarket notification filed by Tetra Corp. with the FDA for Tetrad Model Bs18, Endosurgical Needle Guide Attachment.
| Device ID | K945319 |
| 510k Number | K945319 |
| Device Name: | TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | TETRA CORP. 357 INVERNESS DRIVE SOUTH UNIT A Englewood, CO 80112 -5816 |
| Contact | Clyde Oakley |
| Correspondent | Clyde Oakley TETRA CORP. 357 INVERNESS DRIVE SOUTH UNIT A Englewood, CO 80112 -5816 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-01 |
| Decision Date | 1995-05-04 |