FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
K Number: K080315
·
Decision Apr 23, 2008
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
22
Review Days
77
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Basic Information
- Device Name
- DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
- K Number
- K080315
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Derma Sciences, Inc.
- Date Received
- February 6, 2008
- Decision Date
- April 23, 2008
- 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 Derma Sciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K150985 | Medihoney Wound Gel | Nov 19, 2015 | Substantially Equivalent |
| K133279 | MEDIHONEY WOUND DRESSINGS | Jun 25, 2015 | Substantially Equivalent |
| K110546 | MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY | Jul 27, 2011 | Substantially Equivalent |
| K101793 | MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY | Feb 22, 2011 | Substantially Equivalent |
| K081584 | DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY | Jun 19, 2008 | Substantially Equivalent |
| K072956 | MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY | Nov 7, 2007 | Substantially Equivalent |
| K970660 | DERMAGRAN WOUND MANAGEMENT SYSTEM | Aug 12, 1997 | Substantially Equivalent |
| K963603 | DERMAGRAN HYDROPHILIC OINTMENT | Nov 27, 1996 | Substantially Equivalent for Some Indications |
| K954739 | DERMAGRAN HYDROPHILIC OINTMENT | Nov 2, 1995 | Substantially Equivalent |
| K954743 | DERMAGRAN WOUND DRESSING CLEANER W/ZINC | Nov 2, 1995 | Substantially Equivalent |