FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOACCESS MARROW HARVEST SYSTEM
K Number: K971114
·
Decision Jun 3, 1997
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
47
Applicant Total
3
Review Days
69
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Basic Information
- Device Name
- BIOACCESS MARROW HARVEST SYSTEM
- K Number
- K971114
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioaccess, Inc.
- Date Received
- March 26, 1997
- Decision Date
- June 3, 1997
- Product Code
- GDM
- 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 |
|---|---|---|---|
| GDM | Needle, Aspiration And Injection, Reusable | FDA class 1 | General, Plastic Surgery |
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