The following data is part of a premarket notification filed by N.m. Beale Co. Inc. with the FDA for Ez-mister.
| Device ID | K093584 |
| 510k Number | K093584 |
| Device Name: | EZ-MISTER |
| Classification | Applicator (laryngo-tracheal), Topical Anesthesia |
| Applicant | N.M. BEALE CO. INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau N.M. BEALE CO. INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | CCT |
| CFR Regulation Number | 868.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-19 |
| Decision Date | 2011-03-04 |
| Summary: | summary |