510(k) K853912

MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS by Nucletron-Oldelft Corp. — Product Code JAQ

K853912 is an FDA 510(k) premarket notification submitted by Nucletron-Oldelft Corp. for the device "MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS". The FDA issued a decision of Substantially Equivalent on May 21, 1986. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Nucletron-Oldelft Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1986
Date Received
September 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type