The following data is part of a premarket notification filed by Blairex Laboratories, Inc. with the FDA for Wound Wash Saline, 210 Ml, Model B8552, Wound Wash Saline, 90 Ml, Model B8553.
| Device ID | K083355 |
| 510k Number | K083355 |
| Device Name: | WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 |
| Classification | Dressing, Wound, Drug |
| Applicant | BLAIREX LABORATORIES, INC. 1600 BRIAN DR. Columbus, IN 47201 |
| Contact | Carey Bottom |
| Correspondent | Carey Bottom BLAIREX LABORATORIES, INC. 1600 BRIAN DR. Columbus, IN 47201 |
| 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 | 2008-11-13 |
| Decision Date | 2008-12-29 |
| Summary: | summary |