510(k) K952891

CRONEX LOW ABSORPTION CASSETTE by The DU Pont Co. — Product Code IXA

K952891 is an FDA 510(k) premarket notification submitted by The DU Pont Co. for the device "CRONEX LOW ABSORPTION CASSETTE". The FDA issued a decision of Substantially Equivalent on July 13, 1995. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. The DU Pont Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1995
Date Received
June 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type