Panels › General, Plastic Surgery › Product code QSO · Class 2
Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
Regulation 878.4040
1510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QSO
| Company | 510(k)s | Recalls |
|---|---|---|
| PRIMED Medical Products, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 1, 2026 | K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PRIMED Medical Products, Inc., CA | QSO |
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