510(k) K984607
K984607 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX". The FDA issued a decision of Substantially Equivalent on March 5, 1999. The device falls under product code FBP (Telescope, Rigid, Endoscopic), a Class II device regulated under 21 CFR 876.1500. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1999
- Date Received
- December 28, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Telescope, Rigid, Endoscopic
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type