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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K073705
Device Name MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE
Applicant
SHANDONG QIAOPAI GROUP CO., LTD
No.13,Qinghe Road,Gaoqing County
Zibo,  CN 256300
Applicant Contact MARK JOB
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
FOZ  
Date Received12/31/2007
Decision Date 03/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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