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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K895367
Device Name INTRAVENOUS EXTENSION SET
Applicant
Medical Product Specialists
16 Technology Dr., Suite
145
Irvine,  CA  92718
Applicant Contact DAN HYUN
Correspondent
Medical Product Specialists
16 Technology Dr., Suite
145
Irvine,  CA  92718
Correspondent Contact DAN HYUN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/28/1989
Decision Date 10/06/1989
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
Recalls CDRH Recalls
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