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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K993996
Device Name UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
Applicant
Univec, Inc.
22 Dubon Ct.
Farmingdale,  NY  11735
Applicant Contact S LEVINSON
Correspondent
Univec, Inc.
22 Dubon Ct.
Farmingdale,  NY  11735
Correspondent Contact S LEVINSON
Regulation Number880.5860
Classification Product Code
MEG  
Date Received11/24/1999
Decision Date 07/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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