FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
MWI 400 WOUND DRESSING
K Number: K874470
·
Decision Dec 18, 1987
Classifications
1
FEI Numbers
502
Registration Numbers
502
Same Product Code
106
Applicant Total
11
Review Days
46
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Basic Information
- Device Name
- MWI 400 WOUND DRESSING
- K Number
- K874470
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Med-West, Inc.
- Date Received
- November 2, 1987
- Decision Date
- December 18, 1987
- Product Code
- NAD
- 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 |
|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Med-West, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880877 | CONTRAST INJECTION DEVICE | May 31, 1988 | Substantially Equivalent |
| K880398 | POWER TOILET ELEVATOR | Mar 17, 1988 | Substantially Equivalent |
| K872724 | SHEATH/DILATORS | Sep 15, 1987 | Substantially Equivalent |
| K854612 | ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 | Jan 3, 1986 | Unknown |
| K852162 | MNI 400 INJECTION CAPS | Jun 12, 1985 | Substantially Equivalent |
| K842342 | MWI 888 & 666 DOUBLE LUMEN SUBCLAVIAN | Jun 14, 1984 | Unknown |
| K832124 | CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI | Aug 12, 1983 | Substantially Equivalent |
| K831828 | TEFLON FEMORAL CATHETER MWI 100,10 & | Jul 7, 1983 | Substantially Equivalent |
| K831401 | SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS | Jun 3, 1983 | Substantially Equivalent |
| K831440 | SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 | Jun 3, 1983 | Substantially Equivalent |