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FDA 510(k)

TRULIFE SILICONE BREAST FORM

K-Number: K831831 · 1983-06-30

ApplicantMedeering, Ltd.
Decision Date1983-06-30
Product CodeGBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRULIFE SILICONE BREAST FORM is the device name listed in this FDA 510(k) record. The listed applicant is Medeering, Ltd.. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831831. 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 TRULIFE SILICONE BREAST FORM?

TRULIFE SILICONE BREAST FORM is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Medeering, Ltd.. The 510(k) number is K831831.

When did TRULIFE SILICONE BREAST FORM receive FDA 510(k) clearance?

TRULIFE SILICONE BREAST FORM received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831831.

Who is the listed applicant for TRULIFE SILICONE BREAST FORM?

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

What is the FDA product code for TRULIFE SILICONE BREAST FORM?

The FDA product code for TRULIFE SILICONE BREAST FORM is GBI.

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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.K864785AMOENA BREAST FORMSColoplast Corp.K853822AMOENA BREAST FORMSColoplast Corp.

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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