The following data is part of a premarket notification filed by Glycobiosciences, Inc with the FDA for Ipm Wound Gel Bio.
| Device ID | K123193 |
| 510k Number | K123193 |
| Device Name: | IPM WOUND GEL BIO |
| Classification | Dressing, Wound, Drug |
| Applicant | GLYCOBIOSCIENCES, INC 7 TIMBER COURT Gergetown, Ontario, CA L7g 4s4 |
| Contact | Kevin Drizen |
| Correspondent | Kevin Drizen GLYCOBIOSCIENCES, INC 7 TIMBER COURT Gergetown, Ontario, CA L7g 4s4 |
| 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 | 2012-10-11 |
| Decision Date | 2014-03-03 |
| Summary: | summary |