The following data is part of a premarket notification filed by Iba/griffith with the FDA for Prescott's Light Source Model No. Ii-150.
| Device ID | K964586 |
| 510k Number | K964586 |
| Device Name: | PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | IBA/GRIFFITH P.O. BOX 609 Monument, CO 80132 -0609 |
| Contact | Paul C Redner |
| Correspondent | Paul C Redner IBA/GRIFFITH P.O. BOX 609 Monument, CO 80132 -0609 |
| Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-15 |
| Decision Date | 1997-01-17 |