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FDA 510(k)

FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE

K-Number: K831659 · 1983-08-12

ApplicantAmerican Edwards Laboratories
Decision Date1983-08-12
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K831659. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE?

FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is American Edwards Laboratories. The 510(k) number is K831659.

When did FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE receive FDA 510(k) clearance?

FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE received FDA 510(k) clearance on 1983-08-12, under 510(k) number K831659.

Who is the listed applicant for FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE?

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

What is the FDA product code for FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE?

The FDA product code for FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE is LIT.

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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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