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FDA 510(k)

ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL

K-Number: K823127 · 1982-11-29

ApplicantSyva Co.
Decision Date1982-11-29
Product CodeLAZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1982-11-29 under 510(k) number K823127. The device is classified under product code LAZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL?

ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL is a medical device that received FDA 510(k) clearance on 1982-11-29. The listed applicant is Syva Co.. The 510(k) number is K823127.

When did ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL receive FDA 510(k) clearance?

ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL received FDA 510(k) clearance on 1982-11-29, under 510(k) number K823127.

Who is the listed applicant for ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL?

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

What is the FDA product code for ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL?

The FDA product code for ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL is LAZ.

Related Clinical Trials

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.

Other records listing Syva Co. as applicant

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.

View all 448 devices →

Related Devices (Code: LAZ)

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.

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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