FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.
K Number: K896134
·
Decision Aug 30, 1990
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
4
Review Days
310
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Basic Information
- Device Name
- ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.
- K Number
- K896134
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Goosen Enterprises, Inc.
- Date Received
- October 24, 1989
- Decision Date
- August 30, 1990
- Product Code
- GCX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | FDA class 2 | General Hospital |
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