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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 K990803
Device Name MEDISYSTEMS BUTTONHOLE NEEDLE SETS
Applicant
Medisystems Corp.
1900 K St. NW
Washington,  DC  20006
Applicant Contact LARRY R PILOT
Correspondent
Medisystems Corp.
1900 K St. NW
Washington,  DC  20006
Correspondent Contact LARRY R PILOT
Regulation Number876.5540
Classification Product Code
FIE  
Date Received03/10/1999
Decision Date 01/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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