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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 K231095
Device Name Tamper Evident Cap
Applicant
International Medical Industries, Inc.
2981 Gateway Dr.
Pompano Beach,  FL  33069
Applicant Contact David Meily
Correspondent
International Medical Industries, Inc.
2981 Gateway Dr.
Pompano Beach,  FL  33069
Correspondent Contact Svetlana Abel
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/18/2023
Decision Date 09/04/2024
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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