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FDA 510(k)

HEARING AID IMPRESSION MATERIAL

K-Number: K955288 · 1996-02-02

ApplicantCrown Delta Corp.
Decision Date1996-02-02
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING AID IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Crown Delta Corp.. It received FDA 510(k) clearance on 1996-02-02 under 510(k) number K955288. 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 HEARING AID IMPRESSION MATERIAL?

HEARING AID IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1996-02-02. The listed applicant is Crown Delta Corp.. The 510(k) number is K955288.

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

HEARING AID IMPRESSION MATERIAL received FDA 510(k) clearance on 1996-02-02, under 510(k) number K955288.

Who is the listed applicant for HEARING AID IMPRESSION MATERIAL?

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

What is the FDA product code for HEARING AID IMPRESSION MATERIAL?

The FDA product code for HEARING AID IMPRESSION MATERIAL is ESD.

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Other records listing Crown Delta 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.

K122974TRYOUT-VPS HOLDING PASTEK041028CROWN DELTA HYDROPHILIC IMPRESSION MATERIALK940132PODIATRIC MATERIALK930248VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEMK926150VINYL ADDITION SILICONE SYSTEMK901991SILICONE ELASTOMER PUTTY

View all 18 devices →

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

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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