ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR— 510(k) K853114

Name: FDA 510(k) clearance K853114
Creator: U.S. Food and Drug Administration
Published: 1985-08-06

Substantially Equivalent

Australian Biomedical Corporation , Ltd.

FDA 510(k) clearance K853114 for ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR, Substantially Equivalent on 1985-08-06. Applicant: Australian Biomedical Corporation , Ltd.. Device class: 1.

Clearance details

Applicant: Australian Biomedical Corporation , Ltd.
Product code: Code GAD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1985-07-24
Decision date: 1985-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Australia, AU

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.