The following data is part of a premarket notification filed by Teknar, Inc. with the FDA for Biopsy Guide.
| Device ID | K881605 |
| 510k Number | K881605 |
| Device Name: | BIOPSY GUIDE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TEKNAR, INC. 267 WOLFNER DR. Fenton, MO 63026 -2801 |
| Contact | Kenneth O Head |
| Correspondent | Kenneth O Head TEKNAR, INC. 267 WOLFNER DR. Fenton, MO 63026 -2801 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-29 |
| Decision Date | 1988-06-21 |