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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 K011242
Device Name HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
Applicant
ACUSUPPLY, INC.
3801 NE 207TH ST.
AVENTURA,  FL  33180
Applicant Contact FERES DAGER
Correspondent
ACUSUPPLY, INC.
3801 NE 207TH ST.
AVENTURA,  FL  33180
Correspondent Contact FERES DAGER
Regulation Number880.5580
Classification Product Code
MQX  
Date Received04/23/2001
Decision Date 09/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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