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FDA 510(k)

AMOENA BREAST FORMS

K-Number: K864785 · 1987-01-08

ApplicantColoplast Corp.
Decision Date1987-01-08
Product CodeGBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMOENA BREAST FORMS is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 1987-01-08 under 510(k) number K864785. The device is classified under product code GBI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMOENA BREAST FORMS?

AMOENA BREAST FORMS is a medical device that received FDA 510(k) clearance on 1987-01-08. The listed applicant is Coloplast Corp.. The 510(k) number is K864785.

When did AMOENA BREAST FORMS receive FDA 510(k) clearance?

AMOENA BREAST FORMS received FDA 510(k) clearance on 1987-01-08, under 510(k) number K864785.

Who is the listed applicant for AMOENA BREAST FORMS?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMOENA BREAST FORMS?

The FDA product code for AMOENA BREAST FORMS is GBI.

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Other records listing Coloplast Corp. as applicant

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Related Devices (Code: GBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K880329FACTOR II PROSTHETIC SILICONE ELASTOMERFactor, Ii, Inc.K874279AHH NATURAL BREAST FORMPacific Prosthetics, Inc.K872714S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARYRoseburg SAK864786PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHTColoplast Corp.K853822AMOENA BREAST FORMSColoplast Corp.K851668PROSTHESIS OR SURGICAL PADSVirginia Hall, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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