510(k) K973363
- Device
- NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633
- Applicant
- ML STRATEGIES, INC.
- 510(k) number
- K973363
- Product code
- IWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-07-02
- Date received
- 1997-09-08
- Regulation
- 892.5730
- Classification name
- Source, Isotope, Sealed, Gold, Titanium, Platinum
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALLAN M GREEN
- Address
- One Financial Center Boston MA US 02111 02111
FDA Registration Numbers#
- 1120804
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IWI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K940632 | I-125 RAPID STRAND | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1994-09-02 |
| K912170 | RADIOACTIVE IODINE-125 SOURCES | Best Industries | 1991-08-09 |
| K882449 | CESIUM 137 SOURCE, MODEL CSM-40 | Cis-Us, Inc. | 1989-04-14 |
| K874787 | MODIFIED PALLADIUM SEED MODEL 100 | Theragenics Corp. | 1987-12-22 |
| K852542 | PALLADIUM SEED MODEL 100 | Nuclear Medicine, Inc. | 1986-01-14 |
Legacy Summary#
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FDA Review#
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