FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DERMAGRAN WOUND MANAGEMENT SYSTEM
K Number: K970660
·
Decision Aug 12, 1997
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
22
Review Days
172
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Basic Information
- Device Name
- DERMAGRAN WOUND MANAGEMENT SYSTEM
- K Number
- K970660
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Derma Sciences, Inc.
- Date Received
- February 21, 1997
- Decision Date
- August 12, 1997
- Product Code
- KMF
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
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|---|---|---|---|
| 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 |
| K080315 | DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY | Apr 23, 2008 | Substantially Equivalent |
| K072956 | MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY | Nov 7, 2007 | 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 |