FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BONE MARROW COLLECTION KIT AND STAND
K Number: K871198
·
Decision Nov 6, 1987
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
2
Applicant Total
505
Review Days
227
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Basic Information
- Device Name
- BONE MARROW COLLECTION KIT AND STAND
- K Number
- K871198
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Baxter Healthcare Corp
- Date Received
- March 24, 1987
- Decision Date
- November 6, 1987
- Product Code
- LWE
- Advisory Committee
- Unknown
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LWE | Bone Marrow Collection/Transfusion Kit | FDA class 2 | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LWE), ordered by most recent decision date.
JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)
FDA 510(k)
FDA Class 2
·Unknown
BONE-TEMNO/STERNUM-TEMNO
FDA 510(k)
FDA Class 2
·Unknown
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