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FDA 510(k)

KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK

K-Number: K893655 · 1989-08-23

ApplicantAmerican Orthodontics
Decision Date1989-08-23
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1989-08-23 under 510(k) number K893655. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK?

KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK is a medical device that received FDA 510(k) clearance on 1989-08-23. The listed applicant is American Orthodontics. The 510(k) number is K893655.

When did KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK receive FDA 510(k) clearance?

KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK received FDA 510(k) clearance on 1989-08-23, under 510(k) number K893655.

Who is the listed applicant for KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK?

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

What is the FDA product code for KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK?

The FDA product code for KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK is EJF.

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Related Devices (Code: EJF)

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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