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FDA 510(k)

UNIVERSAL GENERAL USE KIT #7-510-16

K-Number: K914401 · 1991-11-27

ApplicantNorthgate Technologies, Inc.
Decision Date1991-11-27
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL GENERAL USE KIT #7-510-16 is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Technologies, Inc.. It received FDA 510(k) clearance on 1991-11-27 under 510(k) number K914401. 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 UNIVERSAL GENERAL USE KIT #7-510-16?

UNIVERSAL GENERAL USE KIT #7-510-16 is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K914401.

When did UNIVERSAL GENERAL USE KIT #7-510-16 receive FDA 510(k) clearance?

UNIVERSAL GENERAL USE KIT #7-510-16 received FDA 510(k) clearance on 1991-11-27, under 510(k) number K914401.

Who is the listed applicant for UNIVERSAL GENERAL USE KIT #7-510-16?

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

What is the FDA product code for UNIVERSAL GENERAL USE KIT #7-510-16?

The FDA product code for UNIVERSAL GENERAL USE KIT #7-510-16 is HIF.

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Other records listing Northgate Technologies, Inc. as applicant

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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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