FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS
K Number: K083133
·
Decision Oct 30, 2009
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
1
Review Days
372
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Basic Information
- Device Name
- SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS
- K Number
- K083133
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Andover Healthcare, Inc.
- Date Received
- October 23, 2008
- Decision Date
- October 30, 2009
- 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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