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FDA 510(k)

ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR

K-Number: K853114 · 1985-08-06

ApplicantAustralian Biomedical Corporation , Ltd.
Decision Date1985-08-06
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Australian Biomedical Corporation , Ltd.. It received FDA 510(k) clearance on 1985-08-06 under 510(k) number K853114. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR?

ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR is a medical device that received FDA 510(k) clearance on 1985-08-06. The listed applicant is Australian Biomedical Corporation , Ltd.. The 510(k) number is K853114.

When did ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR receive FDA 510(k) clearance?

ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR received FDA 510(k) clearance on 1985-08-06, under 510(k) number K853114.

Who is the listed applicant for ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR?

The FDA 510(k) record lists Australian Biomedical Corporation , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR?

The FDA product code for ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR is GAD.

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Other records listing Australian Biomedical Corporation , Ltd. as applicant

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Related Devices (Code: GAD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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