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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
510(k) Number K201031
Device Name NRFit® Caps, Male and Female Neuraxial Tip Caps
Applicant
International Medical Industries, Inc.
2981 Gateway Dr.
Pompano Beach,  FL  33069
Applicant Contact David Melly
Correspondent
International Medical Industries, Inc.
2981 Gateway Dr.
Pompano Beach,  FL  33069
Correspondent Contact David Meily
Regulation Number880.5860
Classification Product Code
QEH  
Date Received04/20/2020
Decision Date 12/16/2020
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
Predetermined Change
Control Plan Authorized		 No
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