BOUGIE A BOULE— 510(k) K800611

Substantially Equivalent

G.D. Searle and Co.

FDA 510(k) clearance K800611 for BOUGIE A BOULE, Substantially Equivalent on 1980-04-08. Applicant: G.D. Searle and Co.. Device class: 2.

Clearance details

Applicant: G.D. Searle and Co.
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1980-03-17
Decision date: 1980-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.