The following data is part of a premarket notification filed by Diemolding Corp. with the FDA for Vacon Tm.
Device ID | K770369 |
510k Number | K770369 |
Device Name: | VACON TM |
Classification | Bottle, Collection, Breathing System (calibrated) |
Applicant | DIEMOLDING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CBD |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-02-24 |
Decision Date | 1977-03-01 |