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FDA 510(k)

TRILICON BREASE PROSTHESIS DIFFERENT

K-Number: K841171 · 1984-04-25

ApplicantBaurs Krey Assoc., Inc.
Decision Date1984-04-25
Product CodeGBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRILICON BREASE PROSTHESIS DIFFERENT is the device name listed in this FDA 510(k) record. The listed applicant is Baurs Krey Assoc., Inc.. It received FDA 510(k) clearance on 1984-04-25 under 510(k) number K841171. 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 TRILICON BREASE PROSTHESIS DIFFERENT?

TRILICON BREASE PROSTHESIS DIFFERENT is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Baurs Krey Assoc., Inc.. The 510(k) number is K841171.

When did TRILICON BREASE PROSTHESIS DIFFERENT receive FDA 510(k) clearance?

TRILICON BREASE PROSTHESIS DIFFERENT received FDA 510(k) clearance on 1984-04-25, under 510(k) number K841171.

Who is the listed applicant for TRILICON BREASE PROSTHESIS DIFFERENT?

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

What is the FDA product code for TRILICON BREASE PROSTHESIS DIFFERENT?

The FDA product code for TRILICON BREASE PROSTHESIS DIFFERENT is GBI.

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Other records listing Baurs Krey Assoc., 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.

K841252GLATTELAST COMPRESSION PANTY HOSEK841215GLATTELAST COMPRESSION STOCKINGSK841253COMPRESSION STOCKINGS W/WAIST SUSPENS-

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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