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 |