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FDA 510(k)

MODIFICATION TO PANAVIA F

K-Number: K002322 · 2000-09-18

ApplicantKuraray America, Inc.
Decision Date2000-09-18
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PANAVIA F is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray America, Inc.. It received FDA 510(k) clearance on 2000-09-18 under 510(k) number K002322. 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 MODIFICATION TO PANAVIA F?

MODIFICATION TO PANAVIA F is a medical device that received FDA 510(k) clearance on 2000-09-18. The listed applicant is Kuraray America, Inc.. The 510(k) number is K002322.

When did MODIFICATION TO PANAVIA F receive FDA 510(k) clearance?

MODIFICATION TO PANAVIA F received FDA 510(k) clearance on 2000-09-18, under 510(k) number K002322.

Who is the listed applicant for MODIFICATION TO PANAVIA F?

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

What is the FDA product code for MODIFICATION TO PANAVIA F?

The FDA product code for MODIFICATION TO PANAVIA F is EMA.

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Other records listing Kuraray America, Inc. 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.

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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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