510(k) K946293

MILL-ROSE SCOPE CLEANING BRUSH by Mill-Rose Laboratory — Product Code MNL

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