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FDA 510(k)

EXTERNAL BREAST PROSTHESIS

K-Number: K813416 · 1982-01-18

ApplicantSurgical Appliance Industries, Inc.
Decision Date1982-01-18
Product CodeGBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXTERNAL BREAST PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Appliance Industries, Inc.. It received FDA 510(k) clearance on 1982-01-18 under 510(k) number K813416. 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 EXTERNAL BREAST PROSTHESIS?

EXTERNAL BREAST PROSTHESIS is a medical device that received FDA 510(k) clearance on 1982-01-18. The listed applicant is Surgical Appliance Industries, Inc.. The 510(k) number is K813416.

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

EXTERNAL BREAST PROSTHESIS received FDA 510(k) clearance on 1982-01-18, under 510(k) number K813416.

Who is the listed applicant for EXTERNAL BREAST PROSTHESIS?

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

What is the FDA product code for EXTERNAL BREAST PROSTHESIS?

The FDA product code for EXTERNAL BREAST PROSTHESIS is GBI.

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Other records listing Surgical Appliance Industries, 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.

K121106TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLETK821682TRUNCAL ORTHOSISK812401CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. OK812423NEOPRENE KNEE SUPPORTK812422CUSTOM CONTOUR LUMBOSACRAL ORTHOSISK811689CYLINDER KNEE CAST/SPLINT

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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

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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