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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, i.v.
510(k) Number K193528
Device Name Empty EVA Bag
Applicant
Haemotronic, Spa
16, Via Carreri
Mirandola,  IT 41037
Applicant Contact Paola Franciosi
Correspondent
Haemotronic, Spa
16, Via Carreri
Mirandola,  IT 41037
Correspondent Contact Paola Franciosi
Regulation Number880.5025
Classification Product Code
KPE  
Date Received12/19/2019
Decision Date 07/22/2020
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
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