FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIASMA SAFE
K Number: K792185
·
Decision Dec 28, 1979
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
15
Applicant Total
1
Review Days
58
Basic Information
- Device Name
- PIASMA SAFE
- K Number
- K792185
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9100
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- CRY-O-SAFE, INC.
- Date Received
- October 31, 1979
- Decision Date
- December 28, 1979
- Product Code
- KSR
- 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 |
|---|---|---|---|
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | FDA class 2 | Hematology |
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