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FDA 510(k)

TOKUYAMA SOFRELINER

K-Number: K982537 · 1998-08-24

ApplicantTokuyama America, Inc.
Decision Date1998-08-24
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOKUYAMA SOFRELINER is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama America, Inc.. It received FDA 510(k) clearance on 1998-08-24 under 510(k) number K982537. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOKUYAMA SOFRELINER?

TOKUYAMA SOFRELINER is a medical device that received FDA 510(k) clearance on 1998-08-24. The listed applicant is Tokuyama America, Inc.. The 510(k) number is K982537.

When did TOKUYAMA SOFRELINER receive FDA 510(k) clearance?

TOKUYAMA SOFRELINER received FDA 510(k) clearance on 1998-08-24, under 510(k) number K982537.

Who is the listed applicant for TOKUYAMA SOFRELINER?

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

What is the FDA product code for TOKUYAMA SOFRELINER?

The FDA product code for TOKUYAMA SOFRELINER is EBI.

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Other records listing Tokuyama 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.

K022641TOKUYAMA REBASE IIK011854TOKUYAMA M-BONDK011685BISTITE II DCK010267PALFIQUE ESTELITE LV CLEARK002863PALFIQUE ESTELITE LVK993917TOKUYAMA ONE-UP-BOND F

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Related Devices (Code: EBI)

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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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