510(k) K780386
K780386 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "K-Y LUBRICATING JELLY". The FDA issued a decision of Substantially Equivalent on April 13, 1978. The device falls under product code FHX (Jelly, Lubricating, For Transurethral Surgical Instrument), a Class II device regulated under 21 CFR 876.1500. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 1978
- Date Received
- March 10, 1978
- 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