The following data is part of a premarket notification filed by T. Koros Surgical Instruments Corp. with the FDA for Universal Sternum Spreader And I.m.a. Retractor.
| Device ID | K881156 |
| 510k Number | K881156 |
| Device Name: | UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR |
| Classification | Retractor |
| Applicant | T. KOROS SURGICAL INSTRUMENTS CORP. 610 FLINN AVE. Moorpark, CA 93021 |
| Contact | Tibaor Koros |
| Correspondent | Tibaor Koros T. KOROS SURGICAL INSTRUMENTS CORP. 610 FLINN AVE. Moorpark, CA 93021 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-18 |
| Decision Date | 1988-04-05 |