The following data is part of a premarket notification filed by Advancis Medical with the FDA for Advancis Activon Tube.
| Device ID | K101114 |
| 510k Number | K101114 |
| Device Name: | ADVANCIS ACTIVON TUBE |
| Classification | Dressing, Wound, Drug |
| Applicant | Advancis Medical Sidings Road, Lowmoor Industrial Estate Kirby In Ashfield, GB Ng17 7jz |
| Contact | Toni Miller |
| Correspondent | Toni Miller LEC Associates, LLC 26 Chesnut Ridge Road, #12 Montvale, NJ 07645 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-21 |
| Decision Date | 2011-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060031482010 | K101114 | 000 |
| 05060031471199 | K101114 | 000 |