The following data is part of a premarket notification filed by American V. Mueller with the FDA for Yarmo Nasal Cartilage Softener.
Device ID | K812895 |
510k Number | K812895 |
Device Name: | YARMO NASAL CARTILAGE SOFTENER |
Classification | Forceps, Ent |
Applicant | AMERICAN V. MUELLER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KAE |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-15 |
Decision Date | 1981-11-02 |