FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
K Number: K964647
·
Decision Feb 10, 1997
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
4
Review Days
82
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Basic Information
- Device Name
- NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
- K Number
- K964647
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- North American Scientific, Inc.
- Date Received
- November 20, 1996
- Decision Date
- February 10, 1997
- Product Code
- KXK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | FDA class 2 | Radiology |
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