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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 K043506
Device Name ACUPUNCTURE NEEDLES
Applicant
MARKNEW PRODUCTS
3722 AVE, SAUSALITO
IRVINE,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
MARKNEW PRODUCTS
3722 AVE, SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number880.5580
Classification Product Code
MQX  
Date Received12/20/2004
Decision Date 02/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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