FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT
K Number: K891411
·
Decision Dec 18, 1991
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
44
Applicant Total
190
Review Days
1009
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Basic Information
- Device Name
- GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT
- K Number
- K891411
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3720
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Cook, Inc.
- Date Received
- March 14, 1989
- Decision Date
- December 18, 1991
- Product Code
- JCT
- 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 |
|---|---|---|---|
| JCT | Prosthesis, Tracheal, Expandable | FDA class 2 | General, Plastic Surgery |
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