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FDA 510(k)

THE CALIFORNIA SPLINT

K-Number: K854752 · 1985-12-17

ApplicantIntl. Medication Systems, Ltd.
Decision Date1985-12-17
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE CALIFORNIA SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medication Systems, Ltd.. It received FDA 510(k) clearance on 1985-12-17 under 510(k) number K854752. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE CALIFORNIA SPLINT?

THE CALIFORNIA SPLINT is a medical device that received FDA 510(k) clearance on 1985-12-17. The listed applicant is Intl. Medication Systems, Ltd.. The 510(k) number is K854752.

When did THE CALIFORNIA SPLINT receive FDA 510(k) clearance?

THE CALIFORNIA SPLINT received FDA 510(k) clearance on 1985-12-17, under 510(k) number K854752.

Who is the listed applicant for THE CALIFORNIA SPLINT?

The FDA 510(k) record lists Intl. Medication Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE CALIFORNIA SPLINT?

The FDA product code for THE CALIFORNIA SPLINT is DXQ.

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Related Devices (Code: DXQ)

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Official Source

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

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