The following data is part of a premarket notification filed by Imbed Biosciences, Inc. with the FDA for Microlyte Ag.
| Device ID | K153756 |
| 510k Number | K153756 |
| Device Name: | Microlyte Ag |
| Classification | Dressing, Wound, Drug |
| Applicant | IMBED BIOSCIENCES, INC. 5520 NOBEL DRIVE SUITE 100 Madison, WI 53711 |
| Contact | Ankit Agarwa |
| Correspondent | Albert Rego ALBERT REGO, PH.D. 27001 LA PAZ ROAD, SUITE 312 Mission Viejo, CA 92691 |
| 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 | 2015-12-30 |
| Decision Date | 2016-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B519910022 | K153756 | 000 |
| 00850019162110 | K153756 | 000 |
| 00850019162127 | K153756 | 000 |
| 00850019162134 | K153756 | 000 |
| 00850019162141 | K153756 | 000 |
| 00850019162158 | K153756 | 000 |
| 00850019162165 | K153756 | 000 |
| 00850019162172 | K153756 | 000 |
| 00850019162189 | K153756 | 000 |
| 00850019162196 | K153756 | 000 |
| 00850019162202 | K153756 | 000 |
| 00850019162219 | K153756 | 000 |
| 00850019162226 | K153756 | 000 |
| 00860001725711 | K153756 | 000 |
| 00860001725735 | K153756 | 000 |
| B519910012 | K153756 | 000 |
| 00850019162103 | K153756 | 000 |