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510(k) K111392

Device
WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
Applicant
WOOJEON COMPANY
510(k) number
K111392
Product code
MQX  
Decision
Substantially Equivalent (SESE)
Decision date
2011-11-04
Date received
2011-05-18
Regulation
880.5580
Classification name
Needle, Acupuncture, Single Use
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PETER CHUNG
Address
300, Atwood Pittsburgh PA US 15213 15213

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162566AIK Sterile Acupuncture Needles for Single UseChangchun Aik Medical Devices Co., Ltd.2017-05-11
K142760Acuzone Acupuncture Needles, KSC DB Plus Acupuncture NeedlesK.S. Choi Corporation2015-08-25
K150903EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral NaturalMaanshan Bond Medical Instruments Co., Ltd.2015-07-15
K142920KM Needles (Acupuncture Needle)K.M.S., Inc.2015-06-10
K141473SMC ACUPUNCTURE NEEDLESmc Intl., Inc.2014-08-01
K132896CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBEAsia-Med GmbH and CO KG2013-12-02
K103061BIOMATE STERILE ACUPUNCTURE NEEDLEBiomate Medical Devices Technology Co., Ltd.2011-06-20
K092240ACUPUNCTURE NEEDLESHaenglim Seowon Medical Co.2010-04-21
K090199JIAJIAN ACUPUNCTURE NEEDLEWuxi Jiajian Medical Instrument Co., Ltd.2009-08-11
K090910HANSO ACUPUNCTURE NEEDLEHansol Medical Co.2009-06-30
K071524TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINALTcm World, Inc.2008-04-10
K072778BRIO ACUPUNCTURE NEEDLESHelio Medical Supplies, Inc.2007-11-19
K061517PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLESPrime Herbs Corporation2006-11-22
K062448LYRA ACUPUNCTURE NEEDLESHelio Medical Supplies, Inc.2006-09-20
K060392ASP TITANIUMSedatelec2006-04-26

Legacy Summary#

summary

FDA Review#

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