The following data is part of a premarket notification filed by Lifescience Plus, Inc. with the FDA for Bloodstop Hemostatic Gauze; Ix Hemostatic Gauze.
| Device ID | K072681 |
| 510k Number | K072681 |
| Device Name: | BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE |
| Classification | Dressing, Wound, Drug |
| Applicant | LIFESCIENCE PLUS, INC. 22 STONY HILL DRIVE Mystic, CT 06355 |
| Contact | Audry Vitale |
| Correspondent | Audry Vitale LIFESCIENCE PLUS, INC. 22 STONY HILL DRIVE Mystic, CT 06355 |
| 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 | 2007-09-21 |
| Decision Date | 2007-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850744001286 | K072681 | 000 |
| 20850744001108 | K072681 | 000 |
| 20850744001115 | K072681 | 000 |
| 20850744001122 | K072681 | 000 |
| 20850744001139 | K072681 | 000 |
| 20850744001184 | K072681 | 000 |
| 10850744001248 | K072681 | 000 |
| 10850744001255 | K072681 | 000 |
| 10850744001262 | K072681 | 000 |
| 10850744001279 | K072681 | 000 |
| 00850744001098 | K072681 | 000 |