FYB — Gown, Patient Class II
FDA product code FYB covers "Gown, Patient", a Class II medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FYB
- Device Class
- Class II
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K911921 | liaoning-usa | DISPOSABLE ISOLATION GOWN | May 13, 1991 |
| K891820 | bioshield | DISPOSABLE MEDICAL GOWNS | July 24, 1989 |
| K891053 | dispomed | DENTAL BIB | April 12, 1989 |
| K803171 | alba health care | PROCEDURE & RECOVERY PATIENT SUIT | March 4, 1981 |
| K801570 | american convertors div., american pharmaseal | SHIELD DISP. PATIENTS PONCHO GOWNS | July 28, 1980 |
| K771929 | convertors | PEDIATRICS GOWN | November 16, 1977 |