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FDA 510(k)

OPERATING ROOM TRAY

K-Number: K860160 · 1986-02-27

ApplicantMedical Design Concepts, Inc.
Decision Date1986-02-27
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPERATING ROOM TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medical Design Concepts, Inc.. It received FDA 510(k) clearance on 1986-02-27 under 510(k) number K860160. The device is classified under product code FSM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPERATING ROOM TRAY?

OPERATING ROOM TRAY is a medical device that received FDA 510(k) clearance on 1986-02-27. The listed applicant is Medical Design Concepts, Inc.. The 510(k) number is K860160.

When did OPERATING ROOM TRAY receive FDA 510(k) clearance?

OPERATING ROOM TRAY received FDA 510(k) clearance on 1986-02-27, under 510(k) number K860160.

Who is the listed applicant for OPERATING ROOM TRAY?

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

What is the FDA product code for OPERATING ROOM TRAY?

The FDA product code for OPERATING ROOM TRAY is FSM.

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.

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Other records listing Medical Design Concepts, Inc. 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.

K860161HEART CATHETERIZATION TRAY

Related Devices (Code: FSM)

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.

K971217INSTRUMENT TRAY LINERGeneral Hospital Supply Corp.K962328SINGLE USE INSTRUMENT TRAYMedcare Medical Group, Inc.K944025SURGICAL INSTRUMENT TRAYRiley Medical, Inc.K912106ARTHROSCOPY TRAYMedical Device Inspection Co., Inc.K912053OPEN HEART TRAYMedical Device Inspection Co., Inc.K912052HEART CATH TRAYMedical Device Inspection Co., Inc.

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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