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FDA 510(k)

POWERPRESS UNIT

K-Number: K110276 · 2011-11-09

ApplicantHanuri Distribution, Inc.
Decision Date2011-11-09
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POWERPRESS UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Hanuri Distribution, Inc.. It received FDA 510(k) clearance on 2011-11-09 under 510(k) number K110276. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERPRESS UNIT?

POWERPRESS UNIT is a medical device that received FDA 510(k) clearance on 2011-11-09. The listed applicant is Hanuri Distribution, Inc.. The 510(k) number is K110276.

When did POWERPRESS UNIT receive FDA 510(k) clearance?

POWERPRESS UNIT received FDA 510(k) clearance on 2011-11-09, under 510(k) number K110276.

Who is the listed applicant for POWERPRESS UNIT?

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

What is the FDA product code for POWERPRESS UNIT?

The FDA product code for POWERPRESS UNIT is JOW.

Related Clinical Trials

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Other records listing Hanuri Distribution, 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.

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Related Devices (Code: JOW)

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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , 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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