The following data is part of a premarket notification filed by Xomed-treace, Inc. with the FDA for Xomed-treace Alphascope.
| Device ID | K923830 |
| 510k Number | K923830 |
| Device Name: | XOMED-TREACE ALPHASCOPE |
| Classification | Otoscope |
| Applicant | XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
| Contact | Terry C Mcmahon |
| Correspondent | Terry C Mcmahon XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-31 |
| Decision Date | 1992-11-09 |