The following data is part of a premarket notification filed by Medtrade Products Limited with the FDA for Aquanova Ag Super Absorbant Dressing, Aquanova Ag Antimicrobial Dressing.
| Device ID | K100693 |
| 510k Number | K100693 |
| Device Name: | AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | MEDTRADE PRODUCTS LIMITED ELECTRA HOUSE CREW BUSINESS PARK Crewe, Cheshire, GB Cwi 6gl |
| Contact | Jonathan D Ranfield |
| Correspondent | Jonathan D Ranfield MEDTRADE PRODUCTS LIMITED ELECTRA HOUSE CREW BUSINESS PARK Crewe, Cheshire, GB Cwi 6gl |
| 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 | 2010-03-11 |
| Decision Date | 2010-08-10 |
| Summary: | summary |