FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEDRATROL
K Number: K940430
·
Decision Feb 6, 1995
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
4
Applicant Total
5
Review Days
371
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Basic Information
- Device Name
- SEDRATROL
- K Number
- K940430
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Specialties Intl., Inc.
- Date Received
- January 31, 1994
- Decision Date
- February 6, 1995
- Product Code
- GJR
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GJR | Control, Red-Cell | FDA class 2 | Hematology |
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