The following data is part of a premarket notification filed by Beau Rx Solutions, Llc. with the FDA for Beau Rx Scar Care Gel.
| Device ID | K083718 |
| 510k Number | K083718 |
| Device Name: | BEAU RX SCAR CARE GEL |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | BEAU RX SOLUTIONS, LLC. PO BOX 51-1117 Melbourne Beach, FL 32951 |
| Contact | Thomas L Mcgraw |
| Correspondent | Thomas L Mcgraw BEAU RX SOLUTIONS, LLC. PO BOX 51-1117 Melbourne Beach, FL 32951 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-15 |
| Decision Date | 2009-01-26 |
| Summary: | summary |