510(k) K946293
K946293 is an FDA 510(k) premarket notification submitted by Mill-Rose Laboratory for the device "MILL-ROSE SCOPE CLEANING BRUSH". The FDA issued a decision of Substantially Equivalent on February 16, 1995. The device falls under product code MNL (Accessories, Cleaning Brushes, For Endoscope), a Class I device regulated under 21 CFR 876.1500. Mill-Rose Laboratory has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 1995
- Date Received
- December 27, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Cleaning Brushes, For Endoscope
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type