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FDA 510(k)

SURGICAL INSTRUMENT TRAY

K-Number: K854746 · 1985-12-17

ApplicantZbi, Inc.
Decision Date1985-12-17
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL INSTRUMENT TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Zbi, Inc.. It received FDA 510(k) clearance on 1985-12-17 under 510(k) number K854746. 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 SURGICAL INSTRUMENT TRAY?

SURGICAL INSTRUMENT TRAY is a medical device that received FDA 510(k) clearance on 1985-12-17. The listed applicant is Zbi, Inc.. The 510(k) number is K854746.

When did SURGICAL INSTRUMENT TRAY receive FDA 510(k) clearance?

SURGICAL INSTRUMENT TRAY received FDA 510(k) clearance on 1985-12-17, under 510(k) number K854746.

Who is the listed applicant for SURGICAL INSTRUMENT TRAY?

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

What is the FDA product code for SURGICAL INSTRUMENT TRAY?

The FDA product code for SURGICAL INSTRUMENT 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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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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