FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
X-RAY ATTENUATING CREAM
K Number: DEN120022
·
Decision May 9, 2013
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
1
Applicant Total
3
Review Days
183
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Basic Information
- Device Name
- X-RAY ATTENUATING CREAM
- K Number
- DEN120022
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 892.6510
- Medical Specialty
- Radiology
- Decision
- Unknown
- Applicant
- Bloxr Corporation
- Date Received
- November 7, 2012
- Decision Date
- May 9, 2013
- Product Code
- PDK
- 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 |
|---|---|---|---|
| PDK | Cream For X-Ray Attenuation | FDA class 2 | Radiology |
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