510(k) K874680
K874680 is an FDA 510(k) premarket notification submitted by Laser Peripherals, LLC for the device "LASEGUIDE 600A, 600B, 400A, AND 400B". The FDA issued a decision of Substantially Equivalent on March 23, 1988. The device falls under product code FCS (Light, Catheter, Fiberoptic, Glass, Ureteral), a Class II device regulated under 21 CFR 876.4020. Laser Peripherals, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1988
- Date Received
- November 13, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Catheter, Fiberoptic, Glass, Ureteral
- Device Class
- Class II
- Regulation Number
- 876.4020
- Review Panel
- GU
- Submission Type