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FDA 510(k)

AHH NATURAL BREAST FORM

K-Number: K874279 · 1987-10-29

ApplicantPacific Prosthetics, Inc.
Decision Date1987-10-29
Product CodeGBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AHH NATURAL BREAST FORM is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Prosthetics, Inc.. It received FDA 510(k) clearance on 1987-10-29 under 510(k) number K874279. 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 AHH NATURAL BREAST FORM?

AHH NATURAL BREAST FORM is a medical device that received FDA 510(k) clearance on 1987-10-29. The listed applicant is Pacific Prosthetics, Inc.. The 510(k) number is K874279.

When did AHH NATURAL BREAST FORM receive FDA 510(k) clearance?

AHH NATURAL BREAST FORM received FDA 510(k) clearance on 1987-10-29, under 510(k) number K874279.

Who is the listed applicant for AHH NATURAL BREAST FORM?

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

What is the FDA product code for AHH NATURAL BREAST FORM?

The FDA product code for AHH NATURAL 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.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.K851668PROSTHESIS OR SURGICAL PADSVirginia Hall, Inc.

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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