The following data is part of a premarket notification filed by Australian Biomedical Corporation Ltd. with the FDA for Donway Lifting Frame.
| Device ID | K851660 |
| 510k Number | K851660 |
| Device Name: | DONWAY LIFTING FRAME |
| Classification | Stretcher, Hand-carried |
| Applicant | AUSTRALIAN BIOMEDICAL CORPORATION LTD. 39 DEHAVILLAND ROAD MORDIALLOC, VIC. 3195 Australia, AU |
| Contact | Cook |
| Correspondent | Cook AUSTRALIAN BIOMEDICAL CORPORATION LTD. 39 DEHAVILLAND ROAD MORDIALLOC, VIC. 3195 Australia, AU |
| Product Code | FPP |
| CFR Regulation Number | 880.6900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-23 |
| Decision Date | 1985-08-07 |