BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500— 510(k) K062438

Substantially Equivalent

Cook Ob/Gyn

FDA 510(k) clearance K062438 for BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500, Substantially Equivalent on 2006-10-27. Applicant: Cook Ob/Gyn.

Clearance details

Applicant: Cook Ob/Gyn
Product code: Code KNA
Advisory panel: Obstetrics/Gynecology
Date received: 2006-08-21
Decision date: 2006-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

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