FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AXIOM ATRAUM WOUND DRAINS
K Number: K883887
·
Decision Feb 17, 1989
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
26
Applicant Total
4
Review Days
157
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Basic Information
- Device Name
- AXIOM ATRAUM WOUND DRAINS
- K Number
- K883887
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Axiom, Inc.
- Date Received
- September 13, 1988
- Decision Date
- February 17, 1989
- Product Code
- GBS
- 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 |
|---|---|---|---|
| GBS | Catheter, Ventricular, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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