510(k) K911921
- Device
- DISPOSABLE ISOLATION GOWN
- Applicant
- LIAONING-USA CORP.
- 510(k) number
- K911921
- Product code
- FYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-05-13
- Date received
- 1991-04-30
- Regulation
- 878.4040
- Classification name
- Gown, Patient
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAY A BROWN
- Address
- 123 W. Bellevue, Unit#4 Pasadena CA US 91105 91105
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K891820 | DISPOSABLE MEDICAL GOWNS | Bioshield, Inc. | 1989-07-24 |
| K891053 | DENTAL BIB | Dispomed, Inc. | 1989-04-12 |
| K803171 | PROCEDURE & RECOVERY PATIENT SUIT | Alba Health Care | 1981-03-04 |
| K801570 | SHIELD DISP. PATIENTS PONCHO GOWNS | American Convertors Div., American Pharmaseal | 1980-07-28 |
| K771929 | PEDIATRICS GOWN | Convertors | 1977-11-16 |
Legacy Summary#
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FDA Review#
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