The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Flood Sources & Dose Calibrators W/various Nuclids.
Device ID | K850208 |
510k Number | K850208 |
Device Name: | FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS |
Classification | Source, Calibration, Sealed, Nuclear |
Applicant | SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
Contact | Eleanor V Chiu |
Correspondent | Eleanor V Chiu SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
Product Code | IXD |
CFR Regulation Number | 892.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-18 |
Decision Date | 1985-03-26 |