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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 K932074
Device Name MEDISYSTEMS APHERESIS NEEDLE WITH GUARD
Applicant
MEDISYSTEMS CORP.
THREE EMBARCADERO CENTER
11TH FLOOR
SAN FRANCISCO,  CA  94111
Applicant Contact ALAN C HINTON
Correspondent
MEDISYSTEMS CORP.
THREE EMBARCADERO CENTER
11TH FLOOR
SAN FRANCISCO,  CA  94111
Correspondent Contact ALAN C HINTON
Regulation Number876.5540
Classification Product Code
FIE  
Date Received04/28/1993
Decision Date 02/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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