FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SILVERLON ISLAND WOUND DRESSING
K Number: K141573
·
Decision Aug 28, 2014
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
3
Review Days
77
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Basic Information
- Device Name
- SILVERLON ISLAND WOUND DRESSING
- K Number
- K141573
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Argentum Medical
- Date Received
- June 12, 2014
- Decision Date
- August 28, 2014
- 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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