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FDA 510(k)

Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip

K-Number: K192033 · 2020-06-09

ApplicantBennett Jacoby, Dds, Ms, Inc.
Decision Date2020-06-09
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip is the device name listed in this FDA 510(k) record. The listed applicant is Bennett Jacoby, Dds, Ms, Inc.. It received FDA 510(k) clearance on 2020-06-09 under 510(k) number K192033. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip?

Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip is a medical device that received FDA 510(k) clearance on 2020-06-09. The listed applicant is Bennett Jacoby, Dds, Ms, Inc.. The 510(k) number is K192033.

When did Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip receive FDA 510(k) clearance?

Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip received FDA 510(k) clearance on 2020-06-09, under 510(k) number K192033.

Who is the listed applicant for Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip?

The FDA 510(k) record lists Bennett Jacoby, Dds, Ms, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip?

The FDA product code for Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip is DZI.

Related Devices (Code: DZI)

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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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