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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Surgical, General & Plastic Surgery
510(k) Number K982472
Device Name GENICON TROCAR
Applicant
Genicon, LC
573 Waterscape Way
Orlando,  FL  32828
Applicant Contact GARY W HABERLAND
Correspondent
Genicon, LC
573 Waterscape Way
Orlando,  FL  32828
Correspondent Contact GARY W HABERLAND
Regulation Number878.4800
Classification Product Code
GEA  
Date Received07/15/1998
Decision Date 02/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
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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