FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Dakin's Skin and Wound Cleanser
K Number: K150208
·
Decision Jul 21, 2016
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
2
Review Days
538
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Basic Information
- Device Name
- Dakin's Skin and Wound Cleanser
- K Number
- K150208
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Century Pharmaceuticals, Inc.
- Date Received
- January 30, 2015
- Decision Date
- July 21, 2016
- 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 Century Pharmaceuticals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090791 | DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% | Aug 7, 2009 | Substantially Equivalent |