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FDA 510(k)

TWINKY STAR

K-Number: K022797 · 2002-10-10

ApplicantVoco GmbH
Decision Date2002-10-10
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TWINKY STAR is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2002-10-10 under 510(k) number K022797. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TWINKY STAR?

TWINKY STAR is a medical device that received FDA 510(k) clearance on 2002-10-10. The listed applicant is Voco GmbH. The 510(k) number is K022797.

When did TWINKY STAR receive FDA 510(k) clearance?

TWINKY STAR received FDA 510(k) clearance on 2002-10-10, under 510(k) number K022797.

Who is the listed applicant for TWINKY STAR?

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

What is the FDA product code for TWINKY STAR?

The FDA product code for TWINKY STAR is EBF.

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Other records listing Voco GmbH 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: EBF)

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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