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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 K232328
Device Name Insignis™ Syringe Infusion System
Applicant
Innovative Health Sciences, LLC
1108 Kings Hwy, Suite 4
Chester,  NY  10918
Applicant Contact Phil Daetwyler
Correspondent
Bentley Biomedical Consulting, LLC
28241 Crown Valley Pkwy., Suite 510(K)
Laguna Nuguel,  CA  92677
Correspondent Contact Shepard G. Bentley
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Codes
FRN   PKP  
Date Received08/03/2023
Decision Date 03/01/2024
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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