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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 K070988
Device Name SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)
Applicant
Shinchang Medical Co., Ltd.
3762 S. 150 E.
Salt Lake City,  UT  84115
Applicant Contact JAN J FRANK
Correspondent
Shinchang Medical Co., Ltd.
3762 S. 150 E.
Salt Lake City,  UT  84115
Correspondent Contact JAN J FRANK
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/06/2007
Decision Date 08/23/2007
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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