FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOSPAL KITS A1, A2D, AO, & A1D
K Number: K901368
·
Decision Aug 2, 1990
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
35
Applicant Total
3
Review Days
132
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Basic Information
- Device Name
- HEMOSPAL KITS A1, A2D, AO, & A1D
- K Number
- K901368
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Gambro-Hospal, Inc.
- Date Received
- March 23, 1990
- Decision Date
- August 2, 1990
- Product Code
- FJG
- 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 |
|---|---|---|---|
| FJG | Dialyzer, Parallel Flow | FDA class 2 | Gastroenterology, Urology |
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