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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 K943679
Device Name UNIVEC NONRESUSABLE LOCKING SYRINGE
Applicant
Univec, Inc.
999 Franklin Ave.
Garden City,  NY  11530
Applicant Contact RICHARD SAVADSKY
Correspondent
Univec, Inc.
999 Franklin Ave.
Garden City,  NY  11530
Correspondent Contact RICHARD SAVADSKY
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/26/1994
Decision Date 12/12/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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