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FDA 510(k)

DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER

K-Number: K945789 · 1995-02-07

ApplicantDeroyal Industries, Inc.
Decision Date1995-02-07
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1995-02-07 under 510(k) number K945789. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER?

DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER is a medical device that received FDA 510(k) clearance on 1995-02-07. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K945789.

When did DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER receive FDA 510(k) clearance?

DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER received FDA 510(k) clearance on 1995-02-07, under 510(k) number K945789.

Who is the listed applicant for DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER?

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

What is the FDA product code for DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER?

The FDA product code for DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER is HIF.

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Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

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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