The following data is part of a premarket notification filed by Med General with the FDA for Maxi-vac Tm.
Device ID | K790763 |
510k Number | K790763 |
Device Name: | MAXI-VAC TM |
Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
Applicant | MED GENERAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GCY |
CFR Regulation Number | 878.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-18 |
Decision Date | 1979-04-23 |