510(k) K841732

LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM by Sybron Corp. — Product Code IZP

K841732 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM". The FDA issued a decision of Substantially Equivalent on June 5, 1984. The device falls under product code IZP (Programmer, Changer, Film/Cassette, Radiographic), a Class II device regulated under 21 CFR 892.1870. Sybron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1984
Date Received
April 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Programmer, Changer, Film/Cassette, Radiographic
Device Class
Class II
Regulation Number
892.1870
Review Panel
RA
Submission Type