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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 K190305
Device Name Additive Cap
Applicant
International Medical Industries, Inc.
2981 Gateway Dr.
Pompano Beach,  FL  33069
Applicant Contact Peter Lehel
Correspondent
International Medical Industries, Inc.
2981 Gateway Dr.
Pompano Beach,  FL  33069
Correspondent Contact Peter Lehel
Regulation Number880.5025
Classification Product Code
KPE  
Date Received02/12/2019
Decision Date 04/30/2019
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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