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FDA 510(k)

MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP

K-Number: K070814 · 2007-05-30

ApplicantConfluent Surgical,Inc
Decision Date2007-05-30
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Confluent Surgical,Inc. It received FDA 510(k) clearance on 2007-05-30 under 510(k) number K070814. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP?

MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP is a medical device that received FDA 510(k) clearance on 2007-05-30. The listed applicant is Confluent Surgical,Inc. The 510(k) number is K070814.

When did MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP receive FDA 510(k) clearance?

MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP received FDA 510(k) clearance on 2007-05-30, under 510(k) number K070814.

Who is the listed applicant for MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP?

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

What is the FDA product code for MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP?

The FDA product code for MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP is FMF.

Related Clinical Trials

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.

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Other records listing Confluent Surgical,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.

K091315COVIDIEN EXTENDED TIP APPLICATORK072790CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008K061183CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093K050998CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063K042588CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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