FOCUS TOUCH CONCEPTION SYSTEM— 510(k) K112200

Name: FDA 510(k) clearance K112200
Creator: U.S. Food and Drug Administration
Published: 2012-09-06

Substantially Equivalent

Intimate Bridge 2 Conception, Inc.

FDA 510(k) clearance K112200 for FOCUS TOUCH CONCEPTION SYSTEM, Substantially Equivalent on 2012-09-06. Applicant: Intimate Bridge 2 Conception, Inc.. Device class: 2.

Clearance details

Applicant: Intimate Bridge 2 Conception, Inc.
Product code: Code OBB
Device class: Class 2
Regulation: 21 CFR 884.5250
Advisory panel: Obstetrics/Gynecology
Date received: 2011-08-01
Decision date: 2012-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, US

Download summary PDF View on FDA.gov ↗

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