LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE— 510(k) K912839

Name: FDA 510(k) clearance K912839
Creator: U.S. Food and Drug Administration
Published: 1991-09-25

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K912839 for LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE, Substantially Equivalent on 1991-09-25. Applicant: Baxter Healthcare Corp. Device class: 1.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FBW
Device class: Class 1
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1991-06-26
Decision date: 1991-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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