The following data is part of a premarket notification filed by Hemcon Medical Technologies Europe Ltd with the FDA for Guardiva Antimicrobial Haemstatic Iv Dressing.
| Device ID | K121485 |
| 510k Number | K121485 |
| Device Name: | GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | HEMCON MEDICAL TECHNOLOGIES EUROPE LTD 10575 SW CASCADE AVENUE SUITE 130 Portland, OR 97223 -4363 |
| Contact | Barbara Mcgrath |
| Correspondent | Barbara Mcgrath 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 | 2012-05-18 |
| Decision Date | 2012-08-21 |
| Summary: | summary |