FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BENACEL
K Number: K090612
·
Decision Jul 24, 2009
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
40
Applicant Total
4
Review Days
140
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Basic Information
- Device Name
- BENACEL
- K Number
- K090612
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Unicare Biomedical
- Date Received
- March 6, 2009
- Decision Date
- July 24, 2009
- Product Code
- OLR
- 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 |
|---|---|---|---|
| OLR | Oral Wound Dressing | FDA unclassified | Unknown |
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