The following data is part of a premarket notification filed by Australian Biomedical Corporation Ltd. with the FDA for Rotalok Wrist Strap, Rotalok Skin Retractor.
| Device ID | K853114 |
| 510k Number | K853114 |
| Device Name: | ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR |
| Classification | Retractor |
| Applicant | AUSTRALIAN BIOMEDICAL CORPORATION LTD. 39 DEHAVILLAND ROAD MORDIALLOC, VIC. 3195 Australia, AU |
| Contact | J. D Cook |
| Correspondent | J. D Cook AUSTRALIAN BIOMEDICAL CORPORATION LTD. 39 DEHAVILLAND ROAD MORDIALLOC, VIC. 3195 Australia, AU |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-24 |
| Decision Date | 1985-08-06 |