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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K162057
Device Name ConceptoMed Luer-Jack Slip 10ml
Applicant
ConceptoMed AS
Hattvikveien 2
Ballstad,  NO N-8373
Applicant Contact Marit Martinsen
Correspondent
ConceptoMed AS
Hattvikveien 2
Ballstad,  NO N-8373
Correspondent Contact Marit Martinsen
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/26/2016
Decision Date 01/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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