| K-number | K922442 |
| Device name | ISOLATION GOWNS |
| Applicant | Pfb Inter-Apparel Corp. |
| Product code | FYC |
| Device class | Class II |
| Decision date | Oct 12, 1993 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov