510(k) K801570
- Device
- SHIELD DISP. PATIENTS PONCHO GOWNS
- Applicant
- AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
- 510(k) number
- K801570
- Product code
- FYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-07-28
- Date received
- 1980-07-08
- Regulation
- 878.4040
- Classification name
- Gown, Patient
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K911921 | DISPOSABLE ISOLATION GOWN | Liaoning-Usa Corp. | 1991-05-13 |
| 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 |
| K771929 | PEDIATRICS GOWN | Convertors | 1977-11-16 |
Legacy Summary#
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FDA Review#
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