FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Microcyn Antimicrobial Hydrogel
K Number: K173896
·
Decision Apr 2, 2018
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
5
Review Days
101
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Basic Information
- Device Name
- Microcyn Antimicrobial Hydrogel
- K Number
- K173896
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sonoma Pharmaceuticals, Inc.
- Date Received
- December 22, 2017
- Decision Date
- April 2, 2018
- 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 Sonoma Pharmaceuticals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240510 | Microdacyn Hydrogel | Nov 8, 2024 | Substantially Equivalent |
| K233399 | Microdacyn Wound Care Solution | Sep 13, 2024 | Substantially Equivalent |
| K171935 | Alevicyn SG Antimicrobial Gel | Dec 1, 2017 | Substantially Equivalent |
| K172851 | Microcyn Plus Antimicrobial Wound Care Solution | Nov 15, 2017 | Substantially Equivalent |