510(k) K935548
K935548 is an FDA 510(k) premarket notification submitted by Pharmazeutische Fabrik Montavit GmbH for the device "CATHEJELL S STERILE LUBRICATING JELLY". The FDA issued a decision of Substantially Equivalent on March 30, 1994. The device falls under product code FHX (Jelly, Lubricating, For Transurethral Surgical Instrument), a Class II device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 1994
- Date Received
- November 17, 1993
- 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