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FDA 510(k)

PANAVIA 21

K-Number: K933030 · 1994-02-24

ApplicantKuraray Co.
Decision Date1994-02-24
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANAVIA 21 is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Co.. It received FDA 510(k) clearance on 1994-02-24 under 510(k) number K933030. 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 PANAVIA 21?

PANAVIA 21 is a medical device that received FDA 510(k) clearance on 1994-02-24. The listed applicant is Kuraray Co.. The 510(k) number is K933030.

When did PANAVIA 21 receive FDA 510(k) clearance?

PANAVIA 21 received FDA 510(k) clearance on 1994-02-24, under 510(k) number K933030.

Who is the listed applicant for PANAVIA 21?

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

What is the FDA product code for PANAVIA 21?

The FDA product code for PANAVIA 21 is EMA.

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Other records listing Kuraray Co. as applicant

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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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