PKS BILL— 510(k) K122605

Substantially Equivalent

Gyrus Acmi, Inc.

FDA 510(k) clearance K122605 for PKS BILL, Substantially Equivalent on 2012-12-05. Applicant: Gyrus Acmi, Inc..

Clearance details

Applicant: Gyrus Acmi, Inc.
Product code: Code HIN
Advisory panel: Obstetrics/Gynecology
Date received: 2012-08-27
Decision date: 2012-12-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Southborough, MA, US

Download summary PDF View on FDA.gov ↗

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