The following data is part of a premarket notification filed by Brell Mar Products, Inc. with the FDA for Farrors Tmj Cassette Holder.
Device ID | K813506 |
510k Number | K813506 |
Device Name: | FARRORS TMJ CASSETTE HOLDER |
Classification | Applicator, Absorbent Tipped, Non-sterile |
Applicant | BRELL MAR PRODUCTS, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | KXF |
CFR Regulation Number | 880.6025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-12-15 |
Decision Date | 1982-01-29 |