FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THORA-KLEX CHEST DRAINAGE UNIT
K Number: K905448
·
Decision Mar 27, 1991
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
50
Review Days
112
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Basic Information
- Device Name
- THORA-KLEX CHEST DRAINAGE UNIT
- K Number
- K905448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Davol, Inc.
- Date Received
- December 5, 1990
- Decision Date
- March 27, 1991
- 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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