The following data is part of a premarket notification filed by Hanson Medical, Inc. with the FDA for Hanson Medical Calf Implant.
| Device ID | K030808 |
| 510k Number | K030808 |
| Device Name: | HANSON MEDICAL CALF 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 |
|---|---|---|
| B049CCB25S0 | K030808 | 000 |
| B049CCB150 | K030808 | 000 |
| B049CCB14S0 | K030808 | 000 |
| B049CCB140 | K030808 | 000 |
| B049CCB13S0 | K030808 | 000 |
| B049CCB130 | K030808 | 000 |
| B049CCB12S0 | K030808 | 000 |
| B049CCB120 | K030808 | 000 |
| B049CCB11S0 | K030808 | 000 |
| B049CCB15S0 | K030808 | 000 |
| B049CCB210 | K030808 | 000 |
| B049CCB250 | K030808 | 000 |
| B049CCB24S0 | K030808 | 000 |
| B049CCB240 | K030808 | 000 |
| B049CCB23S0 | K030808 | 000 |
| B049CCB230 | K030808 | 000 |
| B049CCB22S0 | K030808 | 000 |
| B049CCB220 | K030808 | 000 |
| B049CCB21S0 | K030808 | 000 |
| B049CCB110 | K030808 | 000 |