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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Acupuncture, Single Use
510(k) Number K002827
Device Name MAC ACUPUNCTURE NEEDLE
Applicant
Haenglim Seowon Corp.
34-69 Leavitt St.
Flushing,  NY  11354
Applicant Contact YUN CHOL CHO
Correspondent
Haenglim Seowon Corp.
34-69 Leavitt St.
Flushing,  NY  11354
Correspondent Contact YUN CHOL CHO
Regulation Number880.5580
Classification Product Code
MQX  
Date Received09/11/2000
Decision Date 02/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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