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FDA 510(k)

PDM SILOXANE PROSTHETIC EAR

K-Number: K832152 · 1983-12-09

ApplicantDelaware Prosthetics, Inc.
Decision Date1983-12-09
Product CodeGBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PDM SILOXANE PROSTHETIC EAR is the device name listed in this FDA 510(k) record. The listed applicant is Delaware Prosthetics, Inc.. It received FDA 510(k) clearance on 1983-12-09 under 510(k) number K832152. 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 PDM SILOXANE PROSTHETIC EAR?

PDM SILOXANE PROSTHETIC EAR is a medical device that received FDA 510(k) clearance on 1983-12-09. The listed applicant is Delaware Prosthetics, Inc.. The 510(k) number is K832152.

When did PDM SILOXANE PROSTHETIC EAR receive FDA 510(k) clearance?

PDM SILOXANE PROSTHETIC EAR received FDA 510(k) clearance on 1983-12-09, under 510(k) number K832152.

Who is the listed applicant for PDM SILOXANE PROSTHETIC EAR?

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

What is the FDA product code for PDM SILOXANE PROSTHETIC EAR?

The FDA product code for PDM SILOXANE PROSTHETIC EAR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Delaware Prosthetics, 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.

K832151PDM SILOXANE PROSTHETIC ORBITK832153PDM SILOXANE PROSTHETIC NOSEK832148PDM SILOXANE PROSTHETIC CHIN IMPLANTK832149PDM SILOXANE PROSTHETIC OBTURATOR

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 SAK864786PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHTColoplast Corp.K864785AMOENA BREAST FORMSColoplast 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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