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FDA 510(k)

RESOUND IMPRESSION MATERIAL

K-Number: K892935 · 1989-07-14

ApplicantResound Corp.
Decision Date1989-07-14
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RESOUND IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Resound Corp.. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K892935. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOUND IMPRESSION MATERIAL?

RESOUND IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Resound Corp.. The 510(k) number is K892935.

When did RESOUND IMPRESSION MATERIAL receive FDA 510(k) clearance?

RESOUND IMPRESSION MATERIAL received FDA 510(k) clearance on 1989-07-14, under 510(k) number K892935.

Who is the listed applicant for RESOUND IMPRESSION MATERIAL?

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

What is the FDA product code for RESOUND IMPRESSION MATERIAL?

The FDA product code for RESOUND IMPRESSION MATERIAL is ELW.

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Other records listing Resound Corp. 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.

K984547DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDSK974081RESOUND STEALTH CICK974257RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)K971605RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTIONK970215AUDALLION II HEARING SYSTEMK964557RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION

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Related Devices (Code: ELW)

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.

K254152Dia-X Sil Light BodyDiaDent Group InternationalK254142Dia-X Sil Heavy BodyDiaDent Group InternationalK254112Dia-X Sil BiteDiaDent Group InternationalK253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);Vigodent Indústria E Comercio LtdaK250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AGK241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.

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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