The following data is part of a premarket notification filed by Medisiss with the FDA for Medisiss Reprocessed Arthroscopic Shavers And Burs.
| Device ID | K113028 |
| 510k Number | K113028 |
| Device Name: | MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS |
| Classification | Arthroscope |
| Applicant | MEDISISS 2747 SW 6TH STREET Redmond, OR 97756 |
| Contact | Joyce Elkins |
| Correspondent | Joyce Elkins MEDISISS 2747 SW 6TH STREET Redmond, OR 97756 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-11 |
| Decision Date | 2011-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888277389752 | K113028 | 000 |
| 20888277388823 | K113028 | 000 |
| 20888277388809 | K113028 | 000 |
| 20080196391995 | K113028 | 000 |
| 20888277388670 | K113028 | 000 |
| 20888277389028 | K113028 | 000 |
| 20888277389516 | K113028 | 000 |
| 20888277389578 | K113028 | 000 |
| 20888277389592 | K113028 | 000 |
| 20888277389677 | K113028 | 000 |
| 20888277390482 | K113028 | 000 |
| 20888277388663 | K113028 | 000 |
| 20888277388304 | K113028 | 000 |