The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Xenon Light Source.
| Device ID | K921315 |
| 510k Number | K921315 |
| Device Name: | PENTAX XENON LIGHT SOURCE |
| Classification | Light Source, Endoscope, Xenon Arc |
| 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 | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-18 |
| Decision Date | 1993-06-25 |