The following data is part of a premarket notification filed by Hemcon Medical Technologies Europe Ltd with the FDA for Guardiva Antimicrobial Haemostatic Iv Dressing, 1 In/ 4mm, Sterile, Guard Iva Antimicrobial Haemostatic Iv Dressing, 1 I.
| Device ID | K093729 |
| 510k Number | K093729 |
| Device Name: | GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I |
| Classification | Dressing, Wound, Drug |
| Applicant | HEMCON MEDICAL TECHNOLOGIES EUROPE LTD 10575 SW CASCADE AVENUE SUITE 130 Portland, OR 97223 -4363 |
| Contact | Kevin Hawkins |
| Correspondent | Kevin Hawkins HEMCON MEDICAL TECHNOLOGIES EUROPE LTD 10575 SW CASCADE AVENUE SUITE 130 Portland, OR 97223 -4363 |
| 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 | 2009-12-03 |
| Decision Date | 2010-06-08 |
| Summary: | summary |