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FDA 510(k)

GENERAL ASPERATOR

K-Number: K895761 · 1989-10-18

ApplicantKolster Methods
Decision Date1989-10-18
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENERAL ASPERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Kolster Methods. It received FDA 510(k) clearance on 1989-10-18 under 510(k) number K895761. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENERAL ASPERATOR?

GENERAL ASPERATOR is a medical device that received FDA 510(k) clearance on 1989-10-18. The listed applicant is Kolster Methods. The 510(k) number is K895761.

When did GENERAL ASPERATOR receive FDA 510(k) clearance?

GENERAL ASPERATOR received FDA 510(k) clearance on 1989-10-18, under 510(k) number K895761.

Who is the listed applicant for GENERAL ASPERATOR?

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

What is the FDA product code for GENERAL ASPERATOR?

The FDA product code for GENERAL ASPERATOR is JCX.

Related Clinical Trials

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Other records listing Kolster Methods 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.

K935820KOLSTER METHODSK895762CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC

Related Devices (Code: JCX)

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.

K250964Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.K243638MV Flow Aspiration Pump (MVFLOWPMP01)MicroventionK251111CaryExcitus ASK243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. d/b/a ev3 NeurovascularK233428Easycess Aspiration PumpGuangzhou Easycess Medical Co.,LtdK222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)Stryker Instruments

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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