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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 K021315
Device Name SURE-LOK
Applicant
Vital Signs, Inc.
11039 E. Lansing Cir.
Englewood,  CO  80112
Applicant Contact THOMAS W DIELMANN
Correspondent
Vital Signs, Inc.
11039 E. Lansing Cir.
Englewood,  CO  80112
Correspondent Contact THOMAS W DIELMANN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/25/2002
Decision Date 08/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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