K853114 is an FDA 510(k) clearance for the ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR. This device is classified as a Retractor (Class I - General Controls, product code GAD).
Submitted by Australian Biomedical Corporation , Ltd. (Australia, AU). The FDA issued a Cleared decision on August 6, 1985, 13 days after receiving the submission on July 24, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K853114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 1985 |
| Decision Date | August 06, 1985 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAD — Retractor |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |