510(k) K963334
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