FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR
K Number: K903403
·
Decision Oct 1, 1990
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
35
Applicant Total
2
Review Days
62
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Basic Information
- Device Name
- CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR
- K Number
- K903403
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.5650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- University of Michigan
- Date Received
- July 31, 1990
- Decision Date
- October 1, 1990
- Product Code
- IWJ
- 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 |
|---|---|---|---|
| IWJ | System, Applicator, Radionuclide, Manual | FDA class 1 | Radiology |
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Other Clearances by University of Michigan
| K Number | Device Name | ||
|---|---|---|---|
| K964968 | MR EXTENSION SET (001) | Feb 27, 1997 | Substantially Equivalent |