The following data is part of a premarket notification filed by T. Koros Surgical Instruments Corp. with the FDA for Discetome Tissue Aspirator.
| Device ID | K953998 |
| 510k Number | K953998 |
| Device Name: | DISCETOME TISSUE ASPIRATOR |
| Classification | Arthroscope |
| Applicant | T. KOROS SURGICAL INSTRUMENTS CORP. 610 FLINN AVE. Moorpark, CA 93021 |
| Contact | Gabriel Koros |
| Correspondent | Gabriel Koros T. KOROS SURGICAL INSTRUMENTS CORP. 610 FLINN AVE. Moorpark, CA 93021 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-24 |
| Decision Date | 1995-12-04 |