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FDA 510(k)

HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL

K-Number: K973927 · 1997-12-11

ApplicantHyunjae Corp.
Decision Date1997-12-11
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Hyunjae Corp.. It received FDA 510(k) clearance on 1997-12-11 under 510(k) number K973927. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL?

HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1997-12-11. The listed applicant is Hyunjae Corp.. The 510(k) number is K973927.

When did HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL receive FDA 510(k) clearance?

HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL received FDA 510(k) clearance on 1997-12-11, under 510(k) number K973927.

Who is the listed applicant for HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL?

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

What is the FDA product code for HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL?

The FDA product code for HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL is ESD.

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Other records listing Hyunjae 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.

K962680HYUNJAE DENTAL IMPRESSION MATERIALS

Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, Inc.

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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