FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INJECTOR FILL TUBE
K Number: K911549
·
Decision Jul 18, 1991
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
204
Applicant Total
4
Review Days
101
Basic Information
- Device Name
- INJECTOR FILL TUBE
- K Number
- K911549
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- THE R GROUP
- Date Received
- April 8, 1991
- Decision Date
- July 18, 1991
- Product Code
- DXT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | FDA class 2 | Cardiovascular |
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