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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K191258
Device Name Intraosseous infusion device
Applicant
Einstein Works, LLC
5312 Elm St.
Houston,  TX  77081
Applicant Contact Linda Taylor
Correspondent
Omedtech, LLC
1725 Signal Ridge Dr., Suite 150
Edmond,  OK  73013
Correspondent Contact David Makanani
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/10/2019
Decision Date 10/23/2019
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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