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FDA 510(k)

OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700

K-Number: K042828 · 2004-12-01

ApplicantYoung O/S, LLC
Decision Date2004-12-01
Product CodeEKR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 is the device name listed in this FDA 510(k) record. The listed applicant is Young O/S, LLC. It received FDA 510(k) clearance on 2004-12-01 under 510(k) number K042828. The device is classified under product code EKR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700?

OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 is a medical device that received FDA 510(k) clearance on 2004-12-01. The listed applicant is Young O/S, LLC. The 510(k) number is K042828.

When did OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 receive FDA 510(k) clearance?

OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 received FDA 510(k) clearance on 2004-12-01, under 510(k) number K042828.

Who is the listed applicant for OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700?

The FDA 510(k) record lists Young O/S, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700?

The FDA product code for OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 is EKR.

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Related Devices (Code: EKR)

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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