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FDA 510(k)

TECNADYNE 20/20 FOG INHIBITOR KIT

K-Number: K940431 · 1994-04-29

ApplicantTecnadyne Scientific, Inc.
Decision Date1994-04-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TECNADYNE 20/20 FOG INHIBITOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Tecnadyne Scientific, Inc.. It received FDA 510(k) clearance on 1994-04-29 under 510(k) number K940431. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECNADYNE 20/20 FOG INHIBITOR KIT?

TECNADYNE 20/20 FOG INHIBITOR KIT is a medical device that received FDA 510(k) clearance on 1994-04-29. The listed applicant is Tecnadyne Scientific, Inc.. The 510(k) number is K940431.

When did TECNADYNE 20/20 FOG INHIBITOR KIT receive FDA 510(k) clearance?

TECNADYNE 20/20 FOG INHIBITOR KIT received FDA 510(k) clearance on 1994-04-29, under 510(k) number K940431.

Who is the listed applicant for TECNADYNE 20/20 FOG INHIBITOR KIT?

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

What is the FDA product code for TECNADYNE 20/20 FOG INHIBITOR KIT?

The FDA product code for TECNADYNE 20/20 FOG INHIBITOR KIT is GCJ.

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Other records listing Tecnadyne Scientific, Inc. 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.

K940891TECNADYNE ENDOSCOPIC INSTRUMENT HOLDERK910926TECNADYNE SURGI-SQUEEZE INFUSION PUMPK912007BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFFK904484BAXTER SINGLE PATIENT USE PRESSURE INFUSOR

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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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