FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BONE & MARROW CLLECTION SYSTEM
K Number: K971268
·
Decision Jul 3, 1997
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
40
Applicant Total
1
Review Days
87
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Basic Information
- Device Name
- BONE & MARROW CLLECTION SYSTEM
- K Number
- K971268
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biomedical International Corp.
- Date Received
- April 7, 1997
- Decision Date
- July 3, 1997
- Product Code
- GEY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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