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FDA 510(k)

GEENEN/ZEBRA GUIDELINES

K-Number: K942677 · 1994-07-21

Decision Date1994-07-21
Product CodeFDE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GEENEN/ZEBRA GUIDELINES is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1994-07-21 under 510(k) number K942677. The device is classified under product code FDE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEENEN/ZEBRA GUIDELINES?

GEENEN/ZEBRA GUIDELINES is a medical device that received FDA 510(k) clearance on 1994-07-21. The listed applicant is Boston Scientific Corp. The 510(k) number is K942677.

When did GEENEN/ZEBRA GUIDELINES receive FDA 510(k) clearance?

GEENEN/ZEBRA GUIDELINES received FDA 510(k) clearance on 1994-07-21, under 510(k) number K942677.

Who is the listed applicant for GEENEN/ZEBRA GUIDELINES?

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

What is the FDA product code for GEENEN/ZEBRA GUIDELINES?

The FDA product code for GEENEN/ZEBRA GUIDELINES is FDE.

Related Clinical Trials

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.

Other records listing Boston Scientific Corp 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: FDE)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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