FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ASAP OTC WOUND DRESSING GEL
K Number: K140483
·
Decision May 20, 2014
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
2
Review Days
83
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Basic Information
- Device Name
- ASAP OTC WOUND DRESSING GEL
- K Number
- K140483
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abl Medical, LLC
- Date Received
- February 26, 2014
- Decision Date
- May 20, 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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Other Clearances by Abl Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K151185 | AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) | Feb 5, 2016 | Substantially Equivalent |