510(k) K935818
K935818 is an FDA 510(k) premarket notification submitted by Cuda Products Co. for the device "ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on July 13, 1994. The device falls under product code GDB (Endoscope, Fiber Optic), a Class II device regulated under 21 CFR 876.1500. Cuda Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 1994
- Date Received
- December 2, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope, Fiber Optic
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type