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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 K093783
Device Name INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT
Applicant
INNOVIA, LLC
12415 SW 136 AVENUE
UNIT 3
MIAMI,  FL  33186
Applicant Contact BRUCE WEBER
Correspondent
INNOVIA, LLC
12415 SW 136 AVENUE
UNIT 3
MIAMI,  FL  33186
Correspondent Contact BRUCE WEBER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/09/2009
Decision Date 08/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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