ESKA MULTISTAGE ESOPHAGEAL BOUGIE— 510(k) K843186

Name: FDA 510(k) clearance K843186
Creator: U.S. Food and Drug Administration
Published: 1985-01-18

Substantially Equivalent

Dacomed Corp.

FDA 510(k) clearance K843186 for ESKA MULTISTAGE ESOPHAGEAL BOUGIE, Substantially Equivalent on 1985-01-18. Applicant: Dacomed Corp.. Device class: 2.

Clearance details

Applicant: Dacomed Corp.
Product code: Code FAT
Device class: Class 2
Regulation: 21 CFR 876.5365
Advisory panel: Gastroenterology, Urology
Date received: 1984-08-13
Decision date: 1985-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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