The following data is part of a premarket notification filed by Allied Biomedical Corp. with the FDA for Duralastic Anatomical Malar Implants.
| Device ID | K971479 |
| 510k Number | K971479 |
| Device Name: | DURALASTIC ANATOMICAL MALAR IMPLANTS |
| Classification | Implant, Malar |
| Applicant | ALLIED BIOMEDICAL CORP. 3850 RAMADA DR., SUITE C-2 Paso Robles, CA 93446 |
| Contact | Gerald Hanson |
| Correspondent | Gerald Hanson ALLIED BIOMEDICAL CORP. 3850 RAMADA DR., SUITE C-2 Paso Robles, CA 93446 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-23 |
| Decision Date | 1997-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724M741 | K971479 | 000 |
| M724M611 | K971479 | 000 |
| M724M711 | K971479 | 000 |
| M724M731 | K971479 | 000 |
| M724M311 | K971479 | 000 |
| M724M321 | K971479 | 000 |
| M724M331 | K971479 | 000 |
| M724M521 | K971479 | 000 |
| M724M531 | K971479 | 000 |
| M724M541 | K971479 | 000 |
| M724M621 | K971479 | 000 |
| M724M631 | K971479 | 000 |
| M724M721 | K971479 | 000 |
| M724M511 | K971479 | 000 |