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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K862002
Device Name MEDISYSTEMS PHERESIS NEEDLE
Applicant
MEDISYSTEMS CORP.
KLEINFELD, KAPLAND & BECKER
1140 NINETEENTH STREET, N.W.
WASHINGTON,  DC  20036
Applicant Contact PETER O SAFIR
Correspondent
MEDISYSTEMS CORP.
KLEINFELD, KAPLAND & BECKER
1140 NINETEENTH STREET, N.W.
WASHINGTON,  DC  20036
Correspondent Contact PETER O SAFIR
Regulation Number876.5540
Classification Product Code
FIE  
Date Received05/23/1986
Decision Date 06/27/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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