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FDA 510(k)

CUSTOM PROCEDURE TRAY

K-Number: K911565 · 1991-08-09

ApplicantVanguard Medical Concepts, Inc.
Decision Date1991-08-09
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUSTOM PROCEDURE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Vanguard Medical Concepts, Inc.. It received FDA 510(k) clearance on 1991-08-09 under 510(k) number K911565. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM PROCEDURE TRAY?

CUSTOM PROCEDURE TRAY is a medical device that received FDA 510(k) clearance on 1991-08-09. The listed applicant is Vanguard Medical Concepts, Inc.. The 510(k) number is K911565.

When did CUSTOM PROCEDURE TRAY receive FDA 510(k) clearance?

CUSTOM PROCEDURE TRAY received FDA 510(k) clearance on 1991-08-09, under 510(k) number K911565.

Who is the listed applicant for CUSTOM PROCEDURE TRAY?

The FDA 510(k) record lists Vanguard Medical Concepts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUSTOM PROCEDURE TRAY?

The FDA product code for CUSTOM PROCEDURE TRAY is KKX.

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Other records listing Vanguard Medical Concepts, Inc. as applicant

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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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