510(k) K140644
K140644 is an FDA 510(k) premarket notification submitted by Ototronix, LLC for the device "PROCEM". The FDA issued a decision of Substantially Equivalent on June 19, 2014. The device falls under product code NEA (Cement, Ear, Nose And Throat), a Class II device regulated under 21 CFR 872.3275. Ototronix, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2014
- Date Received
- March 13, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Ear, Nose And Throat
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- EN
- Submission Type