The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Cs137 Sealed Sources.
Device ID | K850434 |
510k Number | K850434 |
Device Name: | CS137 SEALED SOURCES |
Classification | Source, Brachytherapy, Radionuclide |
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 | KXK |
CFR Regulation Number | 892.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-04 |
Decision Date | 1985-03-26 |