BUTTON LUBRICATOR
Jelly, Lubricating, For Transurethral Surgical Instrument
FIBERTECH INSTRUMENTS, INC.
The following data is part of a premarket notification filed by Fibertech Instruments, Inc. with the FDA for Button Lubricator.
Pre-market Notification Details
| Device ID | K951713 |
| 510k Number | K951713 |
| Device Name: | BUTTON LUBRICATOR |
| Classification | Jelly, Lubricating, For Transurethral Surgical Instrument |
| 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 | FHX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-14 |
| Decision Date | 1995-04-25 |
Trademark Results [BUTTON LUBRICATOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BUTTON LUBRICATOR 74279171 not registered Dead/Abandoned |
Fiber-Tech Medical, Inc. 1992-05-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.