FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS
K Number: K923815
·
Decision Mar 31, 1993
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
6
Review Days
244
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Basic Information
- Device Name
- TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS
- K Number
- K923815
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Laivan Corp.
- Date Received
- July 30, 1992
- Decision Date
- March 31, 1993
- Product Code
- FYA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FYA | Gown, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Laivan Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K890940 | MODIFIED LABELING FOR POLYDERM WBC(TM) | Apr 17, 1989 | 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 |