MAKLER CATHETER— 510(k) K863785

Substantially Equivalent

I M, Inc.

FDA 510(k) clearance K863785 for MAKLER CATHETER, Substantially Equivalent on 1986-12-11. Applicant: I M, Inc..

Clearance details

Applicant: I M, Inc.
Product code: Code HDR
Advisory panel: Obstetrics/Gynecology
Date received: 1986-09-26
Decision date: 1986-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

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