FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SORBACT WOUND DRESSING
K Number: K063059
·
Decision Apr 19, 2007
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
5
Review Days
196
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Basic Information
- Device Name
- SORBACT WOUND DRESSING
- K Number
- K063059
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abigo Medical AB
- Date Received
- October 5, 2006
- Decision Date
- April 19, 2007
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Abigo Medical AB
| K Number | Device Name | ||
|---|---|---|---|
| K171225 | Sorbact Wound Dressing-Ribbon Gauze | Aug 21, 2017 | Substantially Equivalent |
| K153674 | Sorbact Foam Gentle Border, Sorbact Superabsorbent | Jul 1, 2016 | Substantially Equivalent |
| K100591 | SORBACT | Jan 24, 2011 | Substantially Equivalent |
| K920840 | OTOVENT | Oct 5, 1992 | Substantially Equivalent |