The following data is part of a premarket notification filed by Myo-tronics Research, Inc. with the FDA for Mucosal Adjustment Paste Liquid Spray.
Device ID | K833132 |
510k Number | K833132 |
Device Name: | MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY |
Classification | Paper, Articulation |
Applicant | MYO-TRONICS RESEARCH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EFH |
CFR Regulation Number | 872.6140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-13 |
Decision Date | 1984-02-10 |