The following data is part of a premarket notification filed by Biocure, Inc. with the FDA for Gelspray Wound Dressing.
| Device ID | K073663 |
| 510k Number | K073663 |
| Device Name: | GELSPRAY WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | BIOCURE, INC. 20310 SW 48TH STREET Southwest Ranches, FL 33332 |
| Contact | John Greenbaum |
| Correspondent | John Greenbaum BIOCURE, INC. 20310 SW 48TH STREET Southwest Ranches, FL 33332 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-01-30 |
| Summary: | summary |