The following data is part of a premarket notification filed by Fiber Imaging Technologies, Inc. with the FDA for Coldlightsource Pl3000.
| Device ID | K993300 |
| 510k Number | K993300 |
| Device Name: | COLDLIGHTSOURCE PL3000 |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | FIBER IMAGING TECHNOLOGIES, INC. 45 PONTIAC RD. Newton, MA 02468 |
| Contact | Joseph Ress |
| Correspondent | Joseph Ress FIBER IMAGING TECHNOLOGIES, INC. 45 PONTIAC RD. Newton, MA 02468 |
| Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-01 |
| Decision Date | 1999-11-05 |
| Summary: | summary |