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FDA 510(k)

IPOS BREAST PROSTHESIS

K-Number: K792372 · 1979-12-19

ApplicantIpos KG
Decision Date1979-12-19
Product CodeGBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPOS BREAST PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Ipos KG. It received FDA 510(k) clearance on 1979-12-19 under 510(k) number K792372. 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 IPOS BREAST PROSTHESIS?

IPOS BREAST PROSTHESIS is a medical device that received FDA 510(k) clearance on 1979-12-19. The listed applicant is Ipos KG. The 510(k) number is K792372.

When did IPOS BREAST PROSTHESIS receive FDA 510(k) clearance?

IPOS BREAST PROSTHESIS received FDA 510(k) clearance on 1979-12-19, under 510(k) number K792372.

Who is the listed applicant for IPOS BREAST PROSTHESIS?

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

What is the FDA product code for IPOS BREAST PROSTHESIS?

The FDA product code for IPOS BREAST PROSTHESIS 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 SAK864785AMOENA BREAST FORMSColoplast Corp.K864786PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHTColoplast Corp.K853822AMOENA BREAST FORMSColoplast Corp.

Official Source

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

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