Submission Details
| 510(k) Number | K011338 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 02, 2001 |
| Decision Date | September 13, 2001 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
OTO-CEM
Sep 2001
Decision
134d
Days
Class 2
Risk
About This 510(k) Submission
K011338 is an FDA 510(k) clearance for the OTO-CEM, a Cement, Ear, Nose And Throat (Class II — Special Controls, product code NEA), submitted by Ototech, Inc. (Washington, US). The FDA issued a Cleared decision on September 13, 2001, 134 days after receiving the submission on May 2, 2001. 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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