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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K994323
Device Name KAWASUMI LABORATORIES PHILEBOTOMY SET
Applicant
Kawasumi Laboratories Co., Ltd.
1900 K St. NW
Washington,  DC  20006
Applicant Contact DONALD R STONE
Correspondent
Kawasumi Laboratories Co., Ltd.
1900 K St. NW
Washington,  DC  20006
Correspondent Contact DONALD R STONE
Regulation Number880.5440
Classification Product Code
LHI  
Subsequent Product Code
KSB  
Date Received12/22/1999
Decision Date 03/08/2000
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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