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FDA 510(k)

SYNKARA

K-Number: K840445 · 1985-05-16

ApplicantLectec Corp.
Decision Date1985-05-16
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYNKARA is the device name listed in this FDA 510(k) record. The listed applicant is Lectec Corp.. It received FDA 510(k) clearance on 1985-05-16 under 510(k) number K840445. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNKARA?

SYNKARA is a medical device that received FDA 510(k) clearance on 1985-05-16. The listed applicant is Lectec Corp.. The 510(k) number is K840445.

When did SYNKARA receive FDA 510(k) clearance?

SYNKARA received FDA 510(k) clearance on 1985-05-16, under 510(k) number K840445.

Who is the listed applicant for SYNKARA?

The FDA 510(k) record lists Lectec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNKARA?

The FDA product code for SYNKARA is DRX.

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Other records listing Lectec Corp. as applicant

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Related Devices (Code: DRX)

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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