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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 K181369
Device Name Immucise Intradermal Injection System
Applicant
Terumo Corporation
44-1, 2-Chome, Hatagaya
Shibuya-Ku,  JP 151-0072
Applicant Contact Yuko Watanabe
Correspondent
Terumo Medical Corporation
265 Davidson Ave.
Suite 320
Somerset,  NJ  08873
Correspondent Contact Vaarghese Phebe
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
FMF  
Date Received05/23/2018
Decision Date 11/13/2018
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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