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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 K031250
Device Name DBC PRESS ACUPUNCTURE NEEDLES
Applicant
Lhasa Medical, Inc.
234 Libbey Pkwy.
Weymouth,  MA  02189
Applicant Contact KYUNG P RIIHIMAKI
Correspondent
Lhasa Medical, Inc.
234 Libbey Pkwy.
Weymouth,  MA  02189
Correspondent Contact KYUNG P RIIHIMAKI
Regulation Number880.5580
Classification Product Code
MQX  
Date Received04/19/2003
Decision Date 07/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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