510(k) K950719
K950719 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OES UROLOGY". The FDA issued a decision of Substantially Equivalent on December 11, 1996. The device falls under product code EZO (Urethrotome), a Class II device regulated under 21 CFR 876.4770. Olympus America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1996
- Date Received
- February 16, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urethrotome
- Device Class
- Class II
- Regulation Number
- 876.4770
- Review Panel
- GU
- Submission Type