The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Ace System.
| Device ID | K960853 |
| 510k Number | K960853 |
| Device Name: | ACE SYSTEM |
| Classification | Bur, Ear, Nose And Throat |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | David M Timlin |
| Correspondent | David M Timlin XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | EQJ |
| CFR Regulation Number | 874.4140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-01 |
| Decision Date | 1996-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20681490073817 | K960853 | 000 |