K960853 is an FDA 510(k) clearance for the ACE SYSTEM. This device is classified as a Bur, Ear, Nose And Throat (Class I — General Controls, product code EQJ).
Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on April 3, 1996, 33 days after receiving the submission on March 1, 1996.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4140.
| 510(k) Number | K960853 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1996 |
| Decision Date | April 03, 1996 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EQJ — Bur, Ear, Nose And Throat |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 874.4140 |