AMOENA BREAST FORMS— 510(k) K864785

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K864785 for AMOENA BREAST FORMS, Substantially Equivalent on 1987-01-08. Applicant: Coloplast Corp.. Device class: 1.

Clearance details

Applicant: Coloplast Corp.
Product code: Code GBI
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1986-12-08
Decision date: 1987-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GBI

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K874279 — AHH NATURAL BREAST FORM1987-10-29
K872714 — S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY1987-07-21
K864786 — PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT1987-01-08
K853822 — AMOENA BREAST FORMS1985-09-30

More clearances from Coloplast Corp.

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