FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THORA-KLEX CHEST DRAINAGE UNIT
K Number: K896127
·
Decision Jan 24, 1990
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
47
Applicant Total
50
Review Days
93
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Basic Information
- Device Name
- THORA-KLEX CHEST DRAINAGE UNIT
- K Number
- K896127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Davol, Inc.
- Date Received
- October 23, 1989
- Decision Date
- January 24, 1990
- Product Code
- KDQ
- 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 |
|---|---|---|---|
| KDQ | Bottle, Collection, Vacuum | FDA class 2 | General Hospital |
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| K003323 | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 | Jan 22, 2001 | Substantially Equivalent |
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