510(k) K973363
K973363 is an FDA 510(k) premarket notification submitted by Ml Strategies, Inc. for the device "NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633". The FDA issued a decision of Substantially Equivalent on Jul 2, 1998. The device falls under product code IWI (Source, Isotope, Sealed, Gold, Titanium, Platinum), a Class II device regulated under 21 CFR 892.5730. Ml Strategies, Inc. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 2, 1998
- Date Received
- Sep 8, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Source, Isotope, Sealed, Gold, Titanium, Platinum
- Device Class
- Class II
- Regulation Number
- 892.5730
- Review Panel
- RA
- Submission Type
- 510(k)