The following data is part of a premarket notification filed by Alliqua Biomedical, Inc. with the FDA for Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator.
| Device ID | K162721 |
| 510k Number | K162721 |
| Device Name: | Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator |
| Classification | Wound Cleaner, Ultrasound |
| Applicant | ALLIQUA BIOMEDICAL, INC. 11495 VALLEY VIEW ROAD Eden Prairie, MN 55344 |
| Contact | Kathy Simpson |
| Correspondent | Kathy Simpson ALLIQUA BIOMEDICAL, INC. 11495 VALLEY VIEW ROAD Eden Prairie, MN 55344 |
| Product Code | NRB |
| CFR Regulation Number | 878.4410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-29 |
| Decision Date | 2016-12-22 |