FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFIED LABELING FOR POLYDERM WBC(TM)
K Number: K890940
·
Decision Apr 17, 1989
Classifications
1
FEI Numbers
502
Registration Numbers
502
Same Product Code
106
Applicant Total
6
Review Days
54
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Basic Information
- Device Name
- MODIFIED LABELING FOR POLYDERM WBC(TM)
- K Number
- K890940
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Laivan Corp.
- Date Received
- February 22, 1989
- Decision Date
- April 17, 1989
- 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 Laivan Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K923815 | TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS | Mar 31, 1993 | Substantially Equivalent |
| K885205 | AQUADERM | Mar 29, 1989 | Substantially Equivalent for Some Indications |
| K880153 | POLYDERM A+B(TM) | Apr 13, 1988 | Substantially Equivalent for Some Indications |
| K880964 | POLYDERM PEC(TM), POROUS ELASTIC COVER | Mar 17, 1988 | Substantially Equivalent for Some Indications |
| K880206 | POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER | Mar 11, 1988 | Substantially Equivalent for Some Indications |