FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
DERMAGRAN HYDROPHILIC OINTMENT
K Number: K963603
·
Decision Nov 27, 1996
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
22
Review Days
79
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DERMAGRAN HYDROPHILIC OINTMENT
- K Number
- K963603
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Derma Sciences, Inc.
- Date Received
- September 9, 1996
- Decision Date
- November 27, 1996
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KMF), ordered by most recent decision date.
TearRepair Liquid Skin Protectant
FDA 510(k)
FDA Class 1
·General Hospital
Rochal Bioshield Silicone Film
FDA 510(k)
FDA Class 1
·General Hospital
Aleo BME Liquid Bandage
FDA 510(k)
FDA Class 1
·General Hospital
Cavilon Advanced High Endurance Skin Protectant
FDA 510(k)
FDA Class 1
·General Hospital
Atteris No-Sting Skin Protectant
FDA 510(k)
FDA Class 1
·General Hospital
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital
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 |
| 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 |
| K970660 | DERMAGRAN WOUND MANAGEMENT SYSTEM | Aug 12, 1997 | Substantially Equivalent |
| K954739 | DERMAGRAN HYDROPHILIC OINTMENT | Nov 2, 1995 | Substantially Equivalent |
| K954743 | DERMAGRAN WOUND DRESSING CLEANER W/ZINC | Nov 2, 1995 | Substantially Equivalent |