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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K182545
Device Name Tamper Evident Cap with Male Luer Lock
Applicant
International Medical Industries, Inc.
2981 Gateway Dr.
Pompano Beach,  FL  33069
Applicant Contact Kathleen Lavender
Correspondent
International Medical Industries, Inc.
2981 Gateway Dr.
Pompano Beach,  FL  33069
Correspondent Contact Kathleen Lavender
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FMF  
Date Received09/17/2018
Decision Date 01/11/2019
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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