The following data is part of a premarket notification filed by Hanson Medical, Inc. with the FDA for Duralastic Anatomical Malar Implant.
| Device ID | K973574 |
| 510k Number | K973574 |
| Device Name: | DURALASTIC ANATOMICAL MALAR IMPLANT |
| Classification | Implant, Malar |
| 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 | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-19 |
| Decision Date | 1997-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B049M1010 | K973574 | 000 |
| B049M124S0 | K973574 | 000 |
| B049M12S0 | K973574 | 000 |
| B049M130 | K973574 | 000 |
| B049M13S0 | K973574 | 000 |
| B049M210 | K973574 | 000 |
| B049M21S0 | K973574 | 000 |
| B049M220 | K973574 | 000 |
| B049M22S0 | K973574 | 000 |
| B049M230 | K973574 | 000 |
| B049M23S0 | K973574 | 000 |
| B049M240 | K973574 | 000 |
| B049M24S0 | K973574 | 000 |
| B049M310 | K973574 | 000 |
| B049M31S0 | K973574 | 000 |
| B049M320 | K973574 | 000 |
| B049M32S0 | K973574 | 000 |
| B049M410 | K973574 | 000 |
| B049M1240 | K973574 | 000 |
| B049M123S0 | K973574 | 000 |
| B049M101S0 | K973574 | 000 |
| B049M110 | K973574 | 000 |
| B049M1110 | K973574 | 000 |
| B049M111S0 | K973574 | 000 |
| B049M1120 | K973574 | 000 |
| B049M112S0 | K973574 | 000 |
| B049M1130 | K973574 | 000 |
| B049M113S0 | K973574 | 000 |
| B049M1140 | K973574 | 000 |
| B049M114S0 | K973574 | 000 |
| B049M11S0 | K973574 | 000 |
| B049M120 | K973574 | 000 |
| B049M1210 | K973574 | 000 |
| B049M121S0 | K973574 | 000 |
| B049M1220 | K973574 | 000 |
| B049M122S0 | K973574 | 000 |
| B049M1230 | K973574 | 000 |
| B049M41S0 | K973574 | 000 |
| B049M420 | K973574 | 000 |
| B049M720 | K973574 | 000 |
| B049M72S0 | K973574 | 000 |
| B049M730 | K973574 | 000 |
| B049M73S0 | K973574 | 000 |
| B049M740 | K973574 | 000 |
| B049M74S0 | K973574 | 000 |
| B049M810 | K973574 | 000 |
| B049M81S0 | K973574 | 000 |
| B049M820 | K973574 | 000 |
| B049M82S0 | K973574 | 000 |
| B049M830 | K973574 | 000 |
| B049M83S0 | K973574 | 000 |
| B049M910 | K973574 | 000 |
| B049M91S0 | K973574 | 000 |
| B049M920 | K973574 | 000 |
| B049M92S0 | K973574 | 000 |
| B049M930 | K973574 | 000 |
| B049M71S0 | K973574 | 000 |
| B049M710 | K973574 | 000 |
| B049M42S0 | K973574 | 000 |
| B049M430 | K973574 | 000 |
| B049M43S0 | K973574 | 000 |
| B049M440 | K973574 | 000 |
| B049M44S0 | K973574 | 000 |
| B049M510 | K973574 | 000 |
| B049M51S0 | K973574 | 000 |
| B049M520 | K973574 | 000 |
| B049M52S0 | K973574 | 000 |
| B049M530 | K973574 | 000 |
| B049M53S0 | K973574 | 000 |
| B049M610 | K973574 | 000 |
| B049M61S0 | K973574 | 000 |
| B049M620 | K973574 | 000 |
| B049M62S0 | K973574 | 000 |
| B049M630 | K973574 | 000 |
| B049M63S0 | K973574 | 000 |
| B049M93S0 | K973574 | 000 |