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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K002542
Device Name REUSABLE CANNULA
Applicant
GENICON, LC
573 WATERSCAPE WAY
ORLANDO,  FL  32828
Applicant Contact GARY HABERLAND
Correspondent
GENICON, LC
573 WATERSCAPE WAY
ORLANDO,  FL  32828
Correspondent Contact GARY HABERLAND
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/16/2000
Decision Date 10/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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