Submission Details
| 510(k) Number | K140644 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 13, 2014 |
| Decision Date | June 19, 2014 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
PROCEM
Jun 2014
Decision
98d
Days
Class 2
Risk
About This 510(k) Submission
K140644 is an FDA 510(k) clearance for the PROCEM, a Cement, Ear, Nose And Throat (Class II — Special Controls, product code NEA), submitted by Ototronix, LLC (St. Paul, US). The FDA issued a Cleared decision on June 19, 2014, 98 days after receiving the submission on March 13, 2014. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 872.3275.
Device Classification
| Product Code | NEA — Cement, Ear, Nose And Throat |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.3275 |
Manufacturer
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