The following data is part of a premarket notification filed by Allied Biomedical Corp. with the FDA for Duralastic Anatomical Chin Implants.
| Device ID | K971478 |
| 510k Number | K971478 |
| Device Name: | DURALASTIC ANATOMICAL CHIN IMPLANTS |
| Classification | Prosthesis, Chin, Internal |
| 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 | FWP |
| 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 |
|---|---|---|
| M724CH931 | K971478 | 000 |
| M724CH1211 | K971478 | 000 |
| M724CH121 | K971478 | 000 |
| M724CH1151 | K971478 | 000 |
| M724CH1131 | K971478 | 000 |
| M724CH1121 | K971478 | 000 |
| M724CH1111 | K971478 | 000 |
| M724CH921 | K971478 | 000 |
| M724CH731 | K971478 | 000 |
| M724CH721 | K971478 | 000 |
| M724CH411 | K971478 | 000 |
| M724CH311 | K971478 | 000 |
| M724CH221 | K971478 | 000 |
| M724CH14F1 | K971478 | 000 |
| M724CH141 | K971478 | 000 |
| M724CH1331 | K971478 | 000 |
| M724CH1231 | K971478 | 000 |
| M724CH11F1 | K971478 | 000 |
| M724CH1221 | K971478 | 000 |
| M724CH12F1 | K971478 | 000 |
| M724CH131 | K971478 | 000 |
| M724CH911 | K971478 | 000 |
| M724CH831 | K971478 | 000 |
| M724CH821 | K971478 | 000 |
| M724CH811 | K971478 | 000 |
| M724CH741 | K971478 | 000 |
| M724CH631 | K971478 | 000 |
| M724CH621 | K971478 | 000 |
| M724CH611 | K971478 | 000 |
| M724CH521 | K971478 | 000 |
| M724CH511 | K971478 | 000 |
| M724CH421 | K971478 | 000 |
| M724CH331 | K971478 | 000 |
| M724CH321 | K971478 | 000 |
| M724CH211 | K971478 | 000 |
| M724CH13F1 | K971478 | 000 |
| M724CH1321 | K971478 | 000 |
| M724CH1311 | K971478 | 000 |
| M724CH111 | K971478 | 000 |