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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K080660
Device Name IV ADMINISTRATION SET
Applicant
U.S. Safety Syringes Co., Inc.
1676 Village Green
Crofton,  MD  21114
Applicant Contact CHRISTINE SMITH
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/10/2008
Decision Date 05/13/2008
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
Predetermined Change
Control Plan Authorized		 No
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