The following data is part of a premarket notification filed by Future Medical Systems, Sa with the FDA for X-treme Arthroscopic Pump And Shaver System.
| Device ID | K041824 |
| 510k Number | K041824 |
| Device Name: | X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM |
| Classification | Arthroscope |
| Applicant | FUTURE MEDICAL SYSTEMS, SA 265 ROUTE DE LA BARONNE St. Jeannet, FR 06640 |
| Contact | Patrick Janin |
| Correspondent | Patrick Janin FUTURE MEDICAL SYSTEMS, SA 265 ROUTE DE LA BARONNE St. Jeannet, FR 06640 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-06 |
| Decision Date | 2005-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705030743 | K041824 | 000 |
| 10886705030736 | K041824 | 000 |
| 10886705016990 | K041824 | 000 |
| 10886705016938 | K041824 | 000 |