The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xps Straightshot Microbrider System Or Trebay Shaver System.
| Device ID | K973499 |
| 510k Number | K973499 |
| Device Name: | XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM |
| Classification | Arthroscope |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | David Timlin |
| Correspondent | David Timlin XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-16 |
| Decision Date | 1998-01-30 |
| Summary: | summary |