510(k) K862717
K862717 is an FDA 510(k) premarket notification submitted by Simpson/Basye, Inc. for the device "HAND MIRROR (ENDOSCOPE)". The FDA issued a decision of Substantially Equivalent on July 30, 1986. The device falls under product code GCO (Endoscope, Mirror), a Class II device regulated under 21 CFR 876.1500. Simpson/Basye, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1986
- Date Received
- July 17, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope, Mirror
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type