The following data is part of a premarket notification filed by Laser Peripherals Llc. with the FDA for Laseguide 600a, 600b, 400a, And 400b.
| Device ID | K874680 |
| 510k Number | K874680 |
| Device Name: | LASEGUIDE 600A, 600B, 400A, AND 400B |
| Classification | Light, Catheter, Fiberoptic, Glass, Ureteral |
| Applicant | LASER PERIPHERALS LLC. 35 POND PARK RD. #9 Hingham, MA 02043 |
| Contact | Michael N Basel |
| Correspondent | Michael N Basel LASER PERIPHERALS LLC. 35 POND PARK RD. #9 Hingham, MA 02043 |
| Product Code | FCS |
| CFR Regulation Number | 876.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-13 |
| Decision Date | 1988-03-23 |