The following data is part of a premarket notification filed by Xomed-treace, Inc. with the FDA for Xomed-treace Scopesheath.
| Device ID | K933672 |
| 510k Number | K933672 |
| Device Name: | XOMED-TREACE SCOPESHEATH |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| 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 | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-28 |
| Decision Date | 1994-07-18 |