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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 K052846
Device Name TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE
Applicant
MAANSHAN MEDICAL INSTRUMENTS CO., LTD.
13 RED FOX LANE
LITTLETON,  CO  80127
Applicant Contact Kevin Walls
Correspondent
MAANSHAN MEDICAL INSTRUMENTS CO., LTD.
13 RED FOX LANE
LITTLETON,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number880.5580
Classification Product Code
MQX  
Date Received10/07/2005
Decision Date 12/22/2005
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
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