FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HCI ALL PURPOSE DRAIN/CATHETER SET
K Number: K870015
·
Decision Feb 6, 1987
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
26
Applicant Total
5
Review Days
35
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Basic Information
- Device Name
- HCI ALL PURPOSE DRAIN/CATHETER SET
- K Number
- K870015
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Health Care Innovations, Inc.
- Date Received
- January 2, 1987
- Decision Date
- February 6, 1987
- 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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