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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K021197
Device Name SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16
Applicant
Hosuk Co., Ltd.
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Applicant Contact CAROLE STAMP
Correspondent
Hosuk Co., Ltd.
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Correspondent Contact CAROLE STAMP
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received04/16/2002
Decision Date 04/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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