FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DEROYAL WOUND DRESSING
K Number: K912472
·
Decision Oct 2, 1991
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
0
Applicant Total
91
Review Days
120
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Basic Information
- Device Name
- DEROYAL WOUND DRESSING
- K Number
- K912472
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4018
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Deroyal Industries, Inc.
- Date Received
- June 4, 1991
- Decision Date
- October 2, 1991
- Product Code
- MGO
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| MGO | Closure, Wound, Adhesive | FDA class 1 | General, Plastic Surgery |
Other Clearances by Deroyal Industries, Inc.
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|---|---|---|---|
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| K191425 | Hydro-Temp Neonatal Skin Temperature Probe Cover | Jan 21, 2020 | Substantially Equivalent |
| K173072 | Algidex Ag Silver Alginate Wound Dressing | Apr 4, 2018 | Substantially Equivalent |
| K171475 | DeRoyal Laprador Specimen Retrieval System | Aug 17, 2017 | Substantially Equivalent |
| K152978 | DeRoyal Angiography Kits | Mar 25, 2016 | Unknown |