510(k) K991344
K991344 is an FDA 510(k) premarket notification submitted by Worldwide Medical Technologies, LLC for the device "WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS". The FDA issued a decision of Substantially Equivalent on November 5, 1999. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Worldwide Medical Technologies, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1999
- Date Received
- April 19, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source, Brachytherapy, Radionuclide
- Device Class
- Class II
- Regulation Number
- 892.5730
- Review Panel
- RA
- Submission Type