The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Camera, Cleon 720 Large Field Gamma.
Device ID | K790081 |
510k Number | K790081 |
Device Name: | CAMERA, CLEON 720 LARGE FIELD GAMMA |
Classification | Camera, Scintillation (gamma) |
Applicant | UNION CARBIDE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IYX |
CFR Regulation Number | 892.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-12 |
Decision Date | 1979-01-26 |