Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K853667Substantially Equivalent

Bronchial Cytology Brush

E-Z-EM, Inc, Westbury NY / Traditional, Substantially Equivalent

K853667 is the FDA 510(k) clearance record for BRONCHIAL CYTOLOGY BRUSH, cleared for E-Z-Em, Inc. on . FDA records list 56 510(k) clearances for E-Z-Em, Inc., from to . As of , FDA records show no recalls naming K853667.

Clearance record

Decision date
Received
(106 days to decision)
Review panel
Unknown
Applicant
E-Z-Em, Inc. 717 Main St., Westbury NY
Third party review
No