The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xps Straightshot Or Model 2000 Microdebrider System Or Xps Powersculpt.
| Device ID | K992855 |
| 510k Number | K992855 |
| Device Name: | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT |
| Classification | System, Suction, Lipoplasty |
| 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 | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-24 |
| Decision Date | 2000-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490693950 | K992855 | 000 |