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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 K190427
Device Name Immucise
Applicant
Terumo Corporation
44-1, 2-Chome, Hatagaya
Shibuya-Ku,  JP 151-0072
Applicant Contact Rudima L Jackson
Correspondent
Terumo Medical Corporation
265 Davidson Ave Suite 320
Somerset,  NJ  08873
Correspondent Contact Rudima L. Jackson
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received02/22/2019
Decision Date 07/18/2019
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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