The following data is part of a premarket notification filed by Lifescience Plus, Inc. with the FDA for Bloodstop And Bloodstop Ix Hemostatic Gauze, Models Bs-10,bs-11,bs-12,b-13, Bs-ix27, Bs-ix-14, Bsix-15, Bsix-17.
| Device ID | K071578 |
| 510k Number | K071578 |
| Device Name: | BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17 |
| Classification | Dressing, Wound, Drug |
| Applicant | LIFESCIENCE PLUS, INC. 22 STONY HILL DRIVE Mystic, CT 06355 |
| Contact | Audrey Vitale |
| Correspondent | Audrey 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 | 2007-06-08 |
| Decision Date | 2007-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884389155226 | K071578 | 000 |
| 00850744001647 | K071578 | 000 |
| 00850744001630 | K071578 | 000 |
| 00850744001623 | K071578 | 000 |
| 30850744001310 | K071578 | 000 |
| 30850744001297 | K071578 | 000 |
| 00850744001142 | K071578 | 000 |