FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOCKING TRAY
K Number: K023636
·
Decision Nov 22, 2002
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
2
Review Days
23
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Basic Information
- Device Name
- BLOCKING TRAY
- K Number
- K023636
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Southeastern Radiation Products, Inc.
- Date Received
- October 30, 2002
- Decision Date
- November 22, 2002
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by Southeastern Radiation Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K040804 | .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR | Apr 28, 2004 | Substantially Equivalent |