The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Metal Halide Light Source Model Lm 250.
| Device ID | K915274 |
| 510k Number | K915274 |
| Device Name: | METAL HALIDE LIGHT SOURCE MODEL LM 250 |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Lorraine Schwartz |
| Correspondent | Lorraine Schwartz PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-25 |
| Decision Date | 1992-01-23 |