TRANSMYOMETRIAL EMBRYO TRANSFER SET— 510(k) K983595

Name: FDA 510(k) clearance K983595
Creator: U.S. Food and Drug Administration
Published: 1999-02-08

Substantially Equivalent

Cook Ob/Gyn

FDA 510(k) clearance K983595 for TRANSMYOMETRIAL EMBRYO TRANSFER SET, Substantially Equivalent on 1999-02-08. Applicant: Cook Ob/Gyn. Device class: 2.

Clearance details

Applicant: Cook Ob/Gyn
Product code: Code MQF
Device class: Class 2
Regulation: 21 CFR 884.6110
Advisory panel: Obstetrics/Gynecology
Date received: 1998-10-13
Decision date: 1999-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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