FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027
K Number: K092086
·
Decision Jul 30, 2009
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
5
Applicant Total
3
Review Days
21
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Basic Information
- Device Name
- AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027
- K Number
- K092086
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Amerx Health Care Corp.
- Date Received
- July 9, 2009
- Decision Date
- July 30, 2009
- Product Code
- SEJ
- 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 |
|---|---|---|---|
| SEJ | Wound Dressings Containing Topical Analgesics | FDA unclassified | Unknown |
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