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FDA 510(k)

FACTOR II PROSTHETIC SILICONE ELASTOMER

K-Number: K880329 · 1988-06-01

ApplicantFactor, Ii, Inc.
Decision Date1988-06-01
Product CodeGBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FACTOR II PROSTHETIC SILICONE ELASTOMER is the device name listed in this FDA 510(k) record. The listed applicant is Factor, Ii, Inc.. It received FDA 510(k) clearance on 1988-06-01 under 510(k) number K880329. 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 FACTOR II PROSTHETIC SILICONE ELASTOMER?

FACTOR II PROSTHETIC SILICONE ELASTOMER is a medical device that received FDA 510(k) clearance on 1988-06-01. The listed applicant is Factor, Ii, Inc.. The 510(k) number is K880329.

When did FACTOR II PROSTHETIC SILICONE ELASTOMER receive FDA 510(k) clearance?

FACTOR II PROSTHETIC SILICONE ELASTOMER received FDA 510(k) clearance on 1988-06-01, under 510(k) number K880329.

Who is the listed applicant for FACTOR II PROSTHETIC SILICONE ELASTOMER?

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

What is the FDA product code for FACTOR II PROSTHETIC SILICONE ELASTOMER?

The FDA product code for FACTOR II PROSTHETIC SILICONE ELASTOMER is GBI.

Related Clinical Trials

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.

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Other records listing Factor, Ii, Inc. as applicant

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.

K984297MAGNA ABUTMENTK831095ROYALE II

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.

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.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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