The following data is part of a premarket notification filed by Lifescienceplus Inc. with the FDA for Bloodstop Ix Battle Matrix.
| Device ID | K160130 |
| 510k Number | K160130 |
| Device Name: | BloodSTOP IX Battle Matrix |
| Classification | Dressing, Wound, Drug |
| Applicant | LifeSciencePLUS Inc. 2520A Wyandotte St. Mountain View, CA 94043 |
| Contact | Audrey Vitale |
| Correspondent | Audrey Vitale LifeSciencePLUS Inc. 2520A Wyandotte St. Mountain View, CA 94043 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-20 |
| Decision Date | 2016-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850744001586 | K160130 | 000 |
| 00850744001395 | K160130 | 000 |