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FDA 510(k)

S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY

K-Number: K872714 · 1987-07-21

ApplicantRoseburg SA
Decision Date1987-07-21
Product CodeGBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY is the device name listed in this FDA 510(k) record. The listed applicant is Roseburg SA. It received FDA 510(k) clearance on 1987-07-21 under 510(k) number K872714. 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 S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY?

S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY is a medical device that received FDA 510(k) clearance on 1987-07-21. The listed applicant is Roseburg SA. The 510(k) number is K872714.

When did S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY receive FDA 510(k) clearance?

S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY received FDA 510(k) clearance on 1987-07-21, under 510(k) number K872714.

Who is the listed applicant for S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY?

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

What is the FDA product code for S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY?

The FDA product code for S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY is GBI.

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Other records listing Roseburg SA 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.

K931155STAPLE, FIXATION BONE; SCREW FIXATION BONEK890081CALIUS-ISABEL CANOVAS SUNGLASSESK885275ASSENAT-BLESCHET SUNGLASSESK882392BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVESK872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYK874317POIRIER KID-ROLLER MANUAL WHEELCHAIR

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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.K864785AMOENA 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

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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