510(k) K833234
K833234 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK T-MAT L FILM SO-387". The FDA issued a decision of Substantially Equivalent on October 28, 1983. The device falls under product code IWZ (Film, Radiographic), a Class I device regulated under 21 CFR 892.1840. Eastman Kodak Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1983
- Date Received
- September 12, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Film, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1840
- Review Panel
- RA
- Submission Type