The following data is part of a premarket notification filed by Hanson Medical, Inc. with the FDA for Powerflex Pec Implant.
| Device ID | K973729 |
| 510k Number | K973729 |
| Device Name: | POWERFLEX PEC IMPLANT |
| Classification | Implant, Muscle, Pectoralis |
| Applicant | HANSON MEDICAL, INC. P.O. BOX 1160 Kingston, WA 98346 |
| Contact | Erik Hanson |
| Correspondent | Erik Hanson HANSON MEDICAL, INC. P.O. BOX 1160 Kingston, WA 98346 |
| Product Code | MIC |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-30 |
| Decision Date | 1997-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B049ACP110 | K973729 | 000 |
| B049ACP13LS0 | K973729 | 000 |
| B049ACP13R0 | K973729 | 000 |
| B049ACP13RS0 | K973729 | 000 |
| B049ACP140 | K973729 | 000 |
| B049ACP14L0 | K973729 | 000 |
| B049ACP14LS0 | K973729 | 000 |
| B049ACP14R0 | K973729 | 000 |
| B049ACP14RS0 | K973729 | 000 |
| B049ACP210 | K973729 | 000 |
| B049ACP13L0 | K973729 | 000 |
| B049ACP130 | K973729 | 000 |
| B049ACP11L0 | K973729 | 000 |
| B049ACP11LS0 | K973729 | 000 |
| B049ACP11R0 | K973729 | 000 |
| B049ACP11RS0 | K973729 | 000 |
| B049ACP120 | K973729 | 000 |
| B049ACP12L0 | K973729 | 000 |
| B049ACP12LS0 | K973729 | 000 |
| B049ACP12R0 | K973729 | 000 |
| B049ACP12RS0 | K973729 | 000 |
| B049ACP21L0 | K973729 | 000 |
| B049ACP21LS0 | K973729 | 000 |
| B049ACP21R0 | K973729 | 000 |
| B049ACP240 | K973729 | 000 |
| B049ACP24L0 | K973729 | 000 |
| B049ACP24LS0 | K973729 | 000 |
| B049ACP24R0 | K973729 | 000 |
| B049ACP24RS0 | K973729 | 000 |
| B049ACP310 | K973729 | 000 |
| B049ACP31L0 | K973729 | 000 |
| B049ACP31LS0 | K973729 | 000 |
| B049ACP31R0 | K973729 | 000 |
| B049ACP23RS0 | K973729 | 000 |
| B049ACP23R0 | K973729 | 000 |
| B049ACP21RS0 | K973729 | 000 |
| B049ACP220 | K973729 | 000 |
| B049ACP22L0 | K973729 | 000 |
| B049ACP22LS0 | K973729 | 000 |
| B049ACP22R0 | K973729 | 000 |
| B049ACP22RS0 | K973729 | 000 |
| B049ACP230 | K973729 | 000 |
| B049ACP23L0 | K973729 | 000 |
| B049ACP23LS0 | K973729 | 000 |
| B049ACP31RS0 | K973729 | 000 |