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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K921902
Device Name PORT ACCESS NEEDLE
Applicant
Kawasumi Laboratories Co., Ltd.
Kawasumi Bldg. 3-28-15
Minami-Ohi, Shinagawa-Ku
Tokyo,  JP 140
Applicant Contact SHOZO MORIYAMA
Correspondent
Kawasumi Laboratories Co., Ltd.
Kawasumi Bldg. 3-28-15
Minami-Ohi, Shinagawa-Ku
Tokyo,  JP 140
Correspondent Contact SHOZO MORIYAMA
Regulation Number880.5965
Classification Product Code
LJT  
Date Received04/22/1992
Decision Date 07/28/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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