The following data is part of a premarket notification filed by Progress Mankind Technology with the FDA for Pmt Depthalon Depth #2102.
Device ID | K802152 |
510k Number | K802152 |
Device Name: | PMT DEPTHALON DEPTH #2102 |
Classification | Electrode, Depth |
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 | GZL |
CFR Regulation Number | 882.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-08 |
Decision Date | 1980-11-19 |