The following data is part of a premarket notification filed by Nucletron-oldelft Corp. with the FDA for Microselection Interstitial Remote Afterload Sys.
Device ID | K853912 |
510k Number | K853912 |
Device Name: | MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS |
Classification | System, Applicator, Radionuclide, Remote-controlled |
Applicant | NUCLETRON-OLDELFT CORP. 9160 REDBRANCH RD. Columbia, MD 21045 |
Contact | Miles Mount |
Correspondent | Miles Mount NUCLETRON-OLDELFT CORP. 9160 REDBRANCH RD. Columbia, MD 21045 |
Product Code | JAQ |
CFR Regulation Number | 892.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-20 |
Decision Date | 1986-05-21 |