The following data is part of a premarket notification filed by Australian Biomedical Corporation Ltd. with the FDA for Donway Splint.
| Device ID | K843522 |
| 510k Number | K843522 |
| Device Name: | DONWAY SPLINT |
| Classification | Equipment, Traction, Powered |
| Applicant | AUSTRALIAN BIOMEDICAL CORPORATION LTD. 447-459 WILLIANSTOWN ROAD PORT MELBOURNE, VICTORIA 3207 Australia , |
| Contact | Cook |
| Correspondent | Cook AUSTRALIAN BIOMEDICAL CORPORATION LTD. 447-459 WILLIANSTOWN ROAD PORT MELBOURNE, VICTORIA 3207 Australia , |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-07 |
| Decision Date | 1985-02-07 |