FYBClass II
Gown, Patient
21 CFR 878.4040 / General, Plastic Surgery
FYB is the FDA product code for Gown, Patient, a class II device type, regulated under 21 CFR 878.4040. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- FYB
- Device name
- Gown, Patient
- Regulation
- 21 CFR 878.4040
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 6
- Ingested recalls
- 0
Clearances, product code FYB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1980 | 1 |
| 1981 | 1 |
| 1989 | 2 |
| 1991 | 1 |
Applicants with the most clearances
Product code FYB| Applicant | Clearances |
|---|---|
| Alba Health Care | 1 |
| American Convertors Div., American Pharmaseal | 1 |
| Bioshield, Inc. | 1 |
| Convertors | 1 |
| Dispomed, Inc. | 1 |
| Liaoning-Usa Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code FYB.
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