510(k) K083042 ยท FRO Dressing, Wound, Drug
WOUND FLUSH, STERILE WATER & NORMAL SALINE
| Applicant | Nurse Assist, Inc., Carrollton TX, US |
| Decision | Substantially Equivalent, Dec 18, 2008 |
| Received | Oct 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083042
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2023 | Nurse Assist, LLC 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-B Open, Classified |
NGT | None listed |
| Dec 20, 2023 | Nurse Assist, LLC Sterile Water/Saline: Brand Name: Product Name/Product Code:
CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML STERILE WATER BOTTLE/ Open, Classified |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.