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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K864038
Device Name SUPERCATH I.V. CATHETER
Applicant
TOGO MEDIKIT CO., LTD.
SHOEI-SURVGADAI BLDG
1-2 KANDA-SURUGADAI 3 CHOME
CHIYODA-KU TOKYO101 JAPAN,  JP
Applicant Contact HIROAKI NAKAJIMA
Correspondent
TOGO MEDIKIT CO., LTD.
SHOEI-SURVGADAI BLDG
1-2 KANDA-SURUGADAI 3 CHOME
CHIYODA-KU TOKYO101 JAPAN,  JP
Correspondent Contact HIROAKI NAKAJIMA
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received10/16/1986
Decision Date 12/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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