510(k) K934649
K934649 is an FDA 510(k) premarket notification submitted by Galileo Electro-Optics Corp. for the device "GALILEO ENDOSCOPES". The FDA issued a decision of Substantially Equivalent on October 13, 1994. The device falls under product code FBO (Cystourethroscope), a Class II device regulated under 21 CFR 876.1500. Galileo Electro-Optics Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1994
- Date Received
- September 29, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cystourethroscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type