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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 K992653
Device Name SHELLY PROTECTED AV FISTULA NEEDLE
Applicant
Diasol, Inc.
13212 Raymer St.
North Hollywood,  CA  91605
Applicant Contact MONICA ABELES
Correspondent
Diasol, Inc.
13212 Raymer St.
North Hollywood,  CA  91605
Correspondent Contact MONICA ABELES
Regulation Number876.5540
Classification Product Code
FIE  
Date Received08/06/1999
Decision Date 10/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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