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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 K233056
Device Name EpiZact
Applicant
Guidestar Medical Devices
201-2067 Cadboro Bay Rd.
Victoria,  CA V8R 5G4
Applicant Contact Michael Dolphin
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/25/2023
Decision Date 11/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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