Rotalok Wrist Strap, Rotalok Skin Retractor

FDA 510(k) K853114 · Australian Biomedical Corporation , Ltd.

Substantially Equivalent

510(k) numberK853114

Submission

Device name
Rotalok Wrist Strap, Rotalok Skin Retractor
Applicant
Australian Biomedical Corporation , Ltd.
Australia, AU
Received
July 24, 1985
Decision date
August 6, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GAD – Retractor
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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K851660Donway Lifting FrameFPP · Traditional 08/07/1985SE
K843522Donway SplintITH · Traditional 02/07/1985SE

Questions and answers

When was Rotalok Wrist Strap, Rotalok Skin Retractor cleared by the FDA?

Rotalok Wrist Strap, Rotalok Skin Retractor (K853114) received a 510(k) decision of Substantially Equivalent on August 6, 1985, 13 days after the submission was received.

What is the product code of K853114?

The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.