FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ILIAC CREST BONE MARROW ASPIRATION NEEDLE
K Number: K953082
·
Decision Sep 22, 1995
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
47
Applicant Total
505
Review Days
81
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Basic Information
- Device Name
- ILIAC CREST BONE MARROW ASPIRATION NEEDLE
- K Number
- K953082
- 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
- Baxter Healthcare Corp
- Date Received
- July 3, 1995
- Decision Date
- September 22, 1995
- 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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