The following data is part of a premarket notification filed by Progress Mankind Technology with the FDA for Pmt Accupressure Infusion System 3601.
Device ID | K854157 |
510k Number | K854157 |
Device Name: | PMT ACCUPRESSURE INFUSION SYSTEM 3601 |
Classification | Pump, Infusion |
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 | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-10-11 |
Decision Date | 1986-02-13 |