The following data is part of a premarket notification filed by Hanson Medical, Inc. with the FDA for Hanson Scar Ade.
| Device ID | K040307 |
| 510k Number | K040307 |
| Device Name: | HANSON SCAR ADE |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | HANSON MEDICAL, INC. P.O. BOX 1296 Kingston, WA 98346 |
| Contact | Erik Hanson |
| Correspondent | Erik Hanson HANSON MEDICAL, INC. P.O. BOX 1296 Kingston, WA 98346 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-09 |
| Decision Date | 2004-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852869005197 | K040307 | 000 |
| 10852869005033 | K040307 | 000 |
| 10852869005026 | K040307 | 000 |
| 10852869005019 | K040307 | 000 |
| 10852869005002 | K040307 | 000 |