510(k) K963334

JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 by Jamieson Film Co. — Product Code IXX

K963334 is an FDA 510(k) premarket notification submitted by Jamieson Film Co. for the device "JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100". The FDA issued a decision of Substantially Equivalent on September 11, 1996. The device falls under product code IXX (Processor, Cine Film), a Class II device regulated under 21 CFR 892.1900. Jamieson Film Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1996
Date Received
August 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Cine Film
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type