FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
DERMAGRAN WET DRESSING
K Number: K914746
·
Decision Jun 17, 1992
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
22
Review Days
239
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Basic Information
- Device Name
- DERMAGRAN WET DRESSING
- K Number
- K914746
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Derma Sciences, Inc.
- Date Received
- October 22, 1991
- Decision Date
- June 17, 1992
- Product Code
- MGQ
- 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 |
|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | FDA unclassified | Unknown |
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SILVERSEAL
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FDA Unclassified
·Unknown
TENDERWET ACTIVE
FDA 510(k)
FDA Unclassified
·Unknown
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 |
| K963603 | DERMAGRAN HYDROPHILIC OINTMENT | Nov 27, 1996 | Substantially Equivalent for Some Indications |
| K954739 | DERMAGRAN HYDROPHILIC OINTMENT | Nov 2, 1995 | Substantially Equivalent |