510(k) K062826

AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS by Alpha-Omega Services, Inc. — Product Code JAQ

K062826 is an FDA 510(k) premarket notification submitted by Alpha-Omega Services, Inc. for the device "AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS". The FDA issued a decision of Substantially Equivalent on May 22, 2007. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Alpha-Omega Services, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2007
Date Received
September 20, 2006
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