The following data is part of a premarket notification filed by Progress Mankind Technology with the FDA for Pmt 3721-1 Epidural Kit.
Device ID | K883314 |
510k Number | K883314 |
Device Name: | PMT 3721-1 EPIDURAL KIT |
Classification | Anesthesia Conduction Kit |
Applicant | PROGRESS MANKIND TECHNOLOGY BOX 484 Chanhassen, MN 55317 |
Contact | Alfred A Iversen |
Correspondent | Alfred A Iversen PROGRESS MANKIND TECHNOLOGY BOX 484 Chanhassen, MN 55317 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-04 |
Decision Date | 1988-10-28 |