FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RADIOLOGICAL MARKING PEN
K Number: K852160
·
Decision Jul 18, 1985
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
17
Applicant Total
1
Review Days
140
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Basic Information
- Device Name
- RADIOLOGICAL MARKING PEN
- K Number
- K852160
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1640
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Truett Laboratories, Inc.
- Date Received
- February 28, 1985
- Decision Date
- July 18, 1985
- Product Code
- JAC
- 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 |
|---|---|---|---|
| JAC | System, X-Ray, Film Marking, Radiographic | FDA class 1 | Radiology |
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