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FDA 510(k)

BOUGIE A BOULE

K-Number: K800611 · 1980-04-08

ApplicantG.D. Searle and Co.
Decision Date1980-04-08
Product CodeKOE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BOUGIE A BOULE is the device name listed in this FDA 510(k) record. The listed applicant is G.D. Searle and Co.. It received FDA 510(k) clearance on 1980-04-08 under 510(k) number K800611. The device is classified under product code KOE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOUGIE A BOULE?

BOUGIE A BOULE is a medical device that received FDA 510(k) clearance on 1980-04-08. The listed applicant is G.D. Searle and Co.. The 510(k) number is K800611.

When did BOUGIE A BOULE receive FDA 510(k) clearance?

BOUGIE A BOULE received FDA 510(k) clearance on 1980-04-08, under 510(k) number K800611.

Who is the listed applicant for BOUGIE A BOULE?

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

What is the FDA product code for BOUGIE A BOULE?

The FDA product code for BOUGIE A BOULE is KOE.

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Other records listing G.D. Searle and 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.

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Related Devices (Code: KOE)

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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