The following data is part of a premarket notification filed by Progress Mankind Technology with the FDA for Model 1301 Biotac (tm).
| Device ID | K810627 |
| 510k Number | K810627 |
| Device Name: | MODEL 1301 BIOTAC (TM) |
| Classification | Cannula, Surgical, General & Plastic Surgery |
| 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 | GEA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-09 |
| Decision Date | 1981-04-02 |