FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEEDLE, CHIBA UNIVERSITY
K Number: K771108
·
Decision Jul 29, 1977
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
130
Applicant Total
4
Review Days
39
Basic Information
- Device Name
- NEEDLE, CHIBA UNIVERSITY
- K Number
- K771108
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- JOHANNAH MEDICAL SERVICES, INC.
- Date Received
- June 20, 1977
- Decision Date
- July 29, 1977
- Product Code
- FCG
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCG | Biopsy Needle | FDA class 2 | Gastroenterology, Urology |
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