The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Feathertouch Xps Power Rasp Attachment.
| Device ID | K983025 |
| 510k Number | K983025 |
| Device Name: | XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT |
| Classification | Arthroscope |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Debra N Cortner |
| Correspondent | Debra N Cortner 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 | 1998-08-31 |
| Decision Date | 1998-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20681490051532 | K983025 | 000 |
| 20681490051525 | K983025 | 000 |
| 00681490051095 | K983025 | 000 |
| 00681490051088 | K983025 | 000 |
| 20681490049157 | K983025 | 000 |