The following data is part of a premarket notification filed by Hanson Medical, Inc. with the FDA for Hanson Medical Gluteal Implant.
| Device ID | K030809 |
| 510k Number | K030809 |
| Device Name: | HANSON MEDICAL GLUTEAL IMPLANT |
| Classification | Elastomer, Silicone Block |
| Applicant | HANSON MEDICAL, INC. 5662 CALLE REAL, #331 Goleta, CA 93117 |
| Contact | John Harrison |
| Correspondent | John Harrison HANSON MEDICAL, INC. 5662 CALLE REAL, #331 Goleta, CA 93117 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-13 |
| Decision Date | 2003-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B049ACP91S0 | K030809 | 000 |
| B049ACP51L0 | K030809 | 000 |
| B049ACP510 | K030809 | 000 |
| B049ACP42RS0 | K030809 | 000 |
| B049ACP42R0 | K030809 | 000 |
| B049ACP42LS0 | K030809 | 000 |
| B049ACP42L0 | K030809 | 000 |
| B049ACP420 | K030809 | 000 |
| B049ACP41S0 | K030809 | 000 |
| B049ACP41R0 | K030809 | 000 |
| B049ACP41L0 | K030809 | 000 |
| B049ACP51R0 | K030809 | 000 |
| B049ACP51S0 | K030809 | 000 |
| B049ACP520 | K030809 | 000 |
| B049ACP91R0 | K030809 | 000 |
| B049ACP91L0 | K030809 | 000 |
| B049ACP910 | K030809 | 000 |
| B049ACP61S0 | K030809 | 000 |
| B049ACP61R0 | K030809 | 000 |
| B049ACP61L0 | K030809 | 000 |
| B049ACP610 | K030809 | 000 |
| B049ACP52S0 | K030809 | 000 |
| B049ACP52R0 | K030809 | 000 |
| B049ACP52L0 | K030809 | 000 |
| B049ACP410 | K030809 | 000 |