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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Allergen And Vaccine Delivery Needles
510(k) Number K020500
Device Name UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
Applicant
Univec, Inc.
22 Dubon Ct.
Farmingdale,  NY  11735
Applicant Contact R. COHEN
Correspondent
Univec, Inc.
22 Dubon Ct.
Farmingdale,  NY  11735
Correspondent Contact R. COHEN
Regulation Number880.5570
Classification Product Code
SCL  
Date Received02/14/2002
Decision Date 03/19/2002
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
Recalls CDRH Recalls
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