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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 K182765
Device Name 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe
Applicant
TOP Corporation
19-10 Senju Nakai-cho
Adachi-ku,  JP 120-0035
Applicant Contact Sho Yokoya
Correspondent
Jon Gilbert
1641 Jeurissen Lane
Chanhassen,  MN  55317
Correspondent Contact Jonathan Gilbert
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/28/2018
Decision Date 09/03/2019
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
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