TRULIFE SILICONE BREAST FORM— 510(k) K831831

Substantially Equivalent

Medeering, Ltd.

FDA 510(k) clearance K831831 for TRULIFE SILICONE BREAST FORM, Substantially Equivalent on 1983-06-30. Applicant: Medeering, Ltd.. Device class: 1.

Clearance details

Applicant: Medeering, Ltd.
Product code: Code GBI
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1983-06-07
Decision date: 1983-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GBI

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K864785 — AMOENA BREAST FORMS1987-01-08
K864786 — PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT1987-01-08

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