510(k) K913241
K913241 is an FDA 510(k) premarket notification submitted by Jamieson Film Co. for the device "JAMIESON JT-CRP CINE FILM PROCESSOR". The FDA issued a decision of Substantially Equivalent on September 24, 1991. 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 24, 1991
- Date Received
- July 22, 1991
- 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