The following data is part of a premarket notification filed by Glycobiosciences, Inc with the FDA for L.a.m. Imp Wound Gel.
| Device ID | K123113 |
| 510k Number | K123113 |
| Device Name: | L.A.M. IMP WOUND GEL |
| Classification | Dressing, Wound, Drug |
| Applicant | GLYCOBIOSCIENCES, INC 181 LAKESHORE ROAD EAST Mississauga, Ontario, CA L5g 1g2 |
| Contact | James Johnson |
| Correspondent | James Johnson GLYCOBIOSCIENCES, INC 181 LAKESHORE ROAD EAST Mississauga, Ontario, CA L5g 1g2 |
| 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 | 2012-10-03 |
| Decision Date | 2012-12-11 |
| Summary: | summary |