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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
Predetermined Change
Control Plan Authorized		 No
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