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FDA 510(k)

LEKSELL STEREOACTIC SYSTEM

K-Number: K811726 · 1981-07-10

ApplicantDowns Surgical , Ltd.
Decision Date1981-07-10
Product CodeLHF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LEKSELL STEREOACTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Downs Surgical , Ltd.. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811726. The device is classified under product code LHF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEKSELL STEREOACTIC SYSTEM?

LEKSELL STEREOACTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K811726.

When did LEKSELL STEREOACTIC SYSTEM receive FDA 510(k) clearance?

LEKSELL STEREOACTIC SYSTEM received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811726.

Who is the listed applicant for LEKSELL STEREOACTIC SYSTEM?

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

What is the FDA product code for LEKSELL STEREOACTIC SYSTEM?

The FDA product code for LEKSELL STEREOACTIC SYSTEM is LHF.

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Other records listing Downs Surgical , Ltd. as applicant

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Related Devices (Code: LHF)

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.

K8117242M 9810 MICROWAVE OVENTravenol Laboratories, S.A.

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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