510(k) K951713
K951713 is an FDA 510(k) premarket notification submitted by Fibertech Instruments, Inc. for the device "BUTTON LUBRICATOR". The FDA issued a decision of Substantially Equivalent on April 25, 1995. The device falls under product code FHX (Jelly, Lubricating, For Transurethral Surgical Instrument), a Class II device regulated under 21 CFR 876.1500. Fibertech Instruments, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1995
- Date Received
- April 14, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Jelly, Lubricating, For Transurethral Surgical Instrument
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type