The following data is part of a premarket notification filed by Optik with the FDA for Manual Surgical Instruments For Titamed Antwerp.
| Device ID | K896589 |
| 510k Number | K896589 |
| Device Name: | MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP |
| Classification | Screwdriver, Surgical |
| Applicant | OPTIK 2131ESPEY COURT SUITE 7 Criftib, MD 21114 |
| Contact | William M Macfie |
| Correspondent | William M Macfie OPTIK 2131ESPEY COURT SUITE 7 Criftib, MD 21114 |
| Product Code | LRZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-21 |
| Decision Date | 1989-12-27 |