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FDA 510(k)

AQUAPLAST PALATAL STENT

K-Number: K973370 · 1997-12-02

ApplicantWfr/Aquaplast Corp.
Decision Date1997-12-02
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AQUAPLAST PALATAL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Wfr/Aquaplast Corp.. It received FDA 510(k) clearance on 1997-12-02 under 510(k) number K973370. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUAPLAST PALATAL STENT?

AQUAPLAST PALATAL STENT is a medical device that received FDA 510(k) clearance on 1997-12-02. The listed applicant is Wfr/Aquaplast Corp.. The 510(k) number is K973370.

When did AQUAPLAST PALATAL STENT receive FDA 510(k) clearance?

AQUAPLAST PALATAL STENT received FDA 510(k) clearance on 1997-12-02, under 510(k) number K973370.

Who is the listed applicant for AQUAPLAST PALATAL STENT?

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

What is the FDA product code for AQUAPLAST PALATAL STENT?

The FDA product code for AQUAPLAST PALATAL STENT is EMA.

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Other records listing Wfr/Aquaplast 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.

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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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