The following data is part of a premarket notification filed by Progress Mankind Technology with the FDA for Levy Biotac #lx001 Biopsy Probe Holder.
| Device ID | K812744 |
| 510k Number | K812744 |
| Device Name: | LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | PROGRESS MANKIND TECHNOLOGY BOX 464 Hopkins, MN 55343 |
| Contact | Alfred A Iversen |
| Correspondent | Alfred A Iversen PROGRESS MANKIND TECHNOLOGY BOX 464 Hopkins, MN 55343 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-29 |
| Decision Date | 1981-12-03 |