Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K150979
Device Classification Name
System, Applicator, Radionuclide, Remote-Controlled
More FDA Info for this Device
510(K) Number
K150979
Device Name
System, Applicator, Radionuclide, Remote-Controlled
Applicant
Mick Radio-Nuclear Instruments, Inc.
521 Homestead Avenue
Mount Vermon, NY 10550 US
Other 510(k) Applications for this Company
Contact
Chuck Smith
Other 510(k) Applications for this Contact
Regulation Number
892.5700
More FDA Info for this Regulation Number
Classification Product Code
JAQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/2015
Decision Date
05/31/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact