510(k) K093584
K093584 is an FDA 510(k) premarket notification submitted by N.M. Beale Co., Inc. for the device "EZ-MISTER". The FDA issued a decision of Substantially Equivalent on March 4, 2011. The device falls under product code CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia), a Class II device regulated under 21 CFR 868.5170. N.M. Beale Co., Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2011
- Date Received
- November 19, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator (Laryngo-Tracheal), Topical Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5170
- Review Panel
- AN
- Submission Type