The following data is part of a premarket notification filed by Nurse Assist, Inc. with the FDA for Wound Flush, Sterile Water & Normal Saline.
| Device ID | K083042 |
| 510k Number | K083042 |
| Device Name: | WOUND FLUSH, STERILE WATER & NORMAL SALINE |
| Classification | Dressing, Wound, Drug |
| Applicant | NURSE ASSIST, INC. 1415 HALSEY WAY, SUITE 304 Carrollton, TX 75007 -4455 |
| Contact | Denice Gallagher |
| Correspondent | Denice Gallagher NURSE ASSIST, INC. 1415 HALSEY WAY, SUITE 304 Carrollton, TX 75007 -4455 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-10-14 |
| Decision Date | 2008-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521139756 | K083042 | 000 |
| 00850421008822 | K083042 | 000 |
| 00850421008815 | K083042 | 000 |
| 00850421008877 | K083042 | 000 |
| 00850421008839 | K083042 | 000 |
| 00850421008754 | K083042 | 000 |
| 00850421008747 | K083042 | 000 |
| 20885632395939 | K083042 | 000 |
| 40612479228403 | K083042 | 000 |
| 20885632395908 | K083042 | 000 |
| 20885632395878 | K083042 | 000 |
| B15064927764 | K083042 | 000 |
| B15064927750 | K083042 | 000 |
| 00850421008891 | K083042 | 000 |
| 00850421008846 | K083042 | 000 |
| 00850421008785 | K083042 | 000 |
| 00612479199538 | K083042 | 000 |
| 00612479228429 | K083042 | 000 |
| 00612479133761 | K083042 | 000 |
| 10612479240169 | K083042 | 000 |
| 10612479240152 | K083042 | 000 |
| 40612479180305 | K083042 | 000 |
| 40612479168594 | K083042 | 000 |
| 40612479168563 | K083042 | 000 |
| 10612479199535 | K083042 | 000 |
| 00612479228405 | K083042 | 000 |
| 00612479228399 | K083042 | 000 |
| 00612479180307 | K083042 | 000 |
| 00612479168596 | K083042 | 000 |
| 00612479168565 | K083042 | 000 |
| 00850421008198 | K083042 | 000 |