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FDA 510(k)

TIDAL DISTENSION IRRIGATION SET

K-Number: K841362 · 1984-08-02

ApplicantAbbott Laboratories
Decision Date1984-08-02
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TIDAL DISTENSION IRRIGATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1984-08-02 under 510(k) number K841362. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIDAL DISTENSION IRRIGATION SET?

TIDAL DISTENSION IRRIGATION SET is a medical device that received FDA 510(k) clearance on 1984-08-02. The listed applicant is Abbott Laboratories. The 510(k) number is K841362.

When did TIDAL DISTENSION IRRIGATION SET receive FDA 510(k) clearance?

TIDAL DISTENSION IRRIGATION SET received FDA 510(k) clearance on 1984-08-02, under 510(k) number K841362.

Who is the listed applicant for TIDAL DISTENSION IRRIGATION SET?

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

What is the FDA product code for TIDAL DISTENSION IRRIGATION SET?

The FDA product code for TIDAL DISTENSION IRRIGATION SET is GBX.

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Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, Inc.

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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