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FDA 510(k)

TOKUYAMA SOFT RELINING

K-Number: K953589 · 1996-01-18

ApplicantTokuyama America, Inc.
Decision Date1996-01-18
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOKUYAMA SOFT RELINING 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 1996-01-18 under 510(k) number K953589. 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 SOFT RELINING?

TOKUYAMA SOFT RELINING is a medical device that received FDA 510(k) clearance on 1996-01-18. The listed applicant is Tokuyama America, Inc.. The 510(k) number is K953589.

When did TOKUYAMA SOFT RELINING receive FDA 510(k) clearance?

TOKUYAMA SOFT RELINING received FDA 510(k) clearance on 1996-01-18, under 510(k) number K953589.

Who is the listed applicant for TOKUYAMA SOFT RELINING?

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 SOFT RELINING?

The FDA product code for TOKUYAMA SOFT RELINING 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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