YOURS TRULY ASYMMETRICAL BREAST FORM— 510(k) K911247

Name: FDA 510(k) clearance K911247
Creator: U.S. Food and Drug Administration
Published: 1991-03-29

Substantially Equivalent

Jobst Institute, Inc.

FDA 510(k) clearance K911247 for YOURS TRULY ASYMMETRICAL BREAST FORM, Substantially Equivalent on 1991-03-29. Applicant: Jobst Institute, Inc.. Device class: 1.

Clearance details

Applicant: Jobst Institute, Inc.
Product code: Code KCZ
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1991-03-21
Decision date: 1991-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, US

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