The following data is part of a premarket notification filed by Fiberoptic Medical Products, Inc. with the FDA for Endostar(tm) Stylet.
| Device ID | K933598 |
| 510k Number | K933598 |
| Device Name: | ENDOSTAR(TM) STYLET |
| Classification | Stylet, Tracheal Tube |
| Applicant | FIBEROPTIC MEDICAL PRODUCTS, INC. 5100 TILGHMAN ST., SUITE 300 Allentown, PA 18104 |
| Contact | Richard W Holt |
| Correspondent | Richard W Holt FIBEROPTIC MEDICAL PRODUCTS, INC. 5100 TILGHMAN ST., SUITE 300 Allentown, PA 18104 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-26 |
| Decision Date | 1994-01-25 |