The following data is part of a premarket notification filed by Fibertech Instruments, Inc. with the FDA for Scopejockey.
| Device ID | K940780 |
| 510k Number | K940780 |
| Device Name: | SCOPEJOCKEY |
| Classification | Endoscopic Storage Cover |
| Applicant | FIBERTECH INSTRUMENTS, INC. 5020 CAMPBELL BLVD., SUITE K Baltimore, MD 21236 |
| Contact | Frank Majerowicz |
| Correspondent | Frank Majerowicz FIBERTECH INSTRUMENTS, INC. 5020 CAMPBELL BLVD., SUITE K Baltimore, MD 21236 |
| Product Code | OCU |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-22 |
| Decision Date | 1994-05-10 |