FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
K Number: K090489
·
Decision May 14, 2009
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
28
Review Days
78
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Basic Information
- Device Name
- ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
- K Number
- K090489
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kci USA, Inc.
- Date Received
- February 25, 2009
- Decision Date
- May 14, 2009
- Product Code
- FTL
- 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
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| K181507 | PREVENA RESTOR(TM) Incision Management System | Feb 15, 2019 | Substantially Equivalent |
| K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System | Jun 1, 2018 | Substantially Equivalent |
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