FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
K Number: K100847
·
Decision May 21, 2010
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
3
Review Days
57
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Basic Information
- Device Name
- SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
- K Number
- K100847
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biocompatibles, Inc.
- Date Received
- March 25, 2010
- Decision Date
- May 21, 2010
- 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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