The following data is part of a premarket notification filed by Pmt with the FDA for Invac W/various Models.
Device ID | K831116 |
510k Number | K831116 |
Device Name: | INVAC W/VARIOUS MODELS |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | PMT Box 464 Hopkins, MN 55343 |
Contact | Alfred A Iversen |
Correspondent | Alfred A Iversen PMT Box 464 Hopkins, MN 55343 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-05 |
Decision Date | 1983-08-12 |