510(k) K993472

SEGMENTED VAGINAL APPLICATOR by Mick Radio-Nuclear Instruments, Inc. — Product Code JAQ

K993472 is an FDA 510(k) premarket notification submitted by Mick Radio-Nuclear Instruments, Inc. for the device "SEGMENTED VAGINAL APPLICATOR". The FDA issued a decision of Substantially Equivalent on January 12, 2000. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Mick Radio-Nuclear Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2000
Date Received
October 14, 1999
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