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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 K022110
Device Name KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.
Applicant
Kawasumi Laboratories, Inc.
1800 Massachusetts Ave.
NW Suite 200
Washington,  DC  20036
Applicant Contact DONALD R STONE
Correspondent
Kawasumi Laboratories, Inc.
1800 Massachusetts Ave.
NW Suite 200
Washington,  DC  20036
Correspondent Contact DONALD R STONE
Regulation Number880.5965
Classification Product Code
LJT  
Subsequent Product Code
FMI  
Date Received06/28/2002
Decision Date 09/12/2002
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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