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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 K031098
Device Name 3-CCD DIGITAL CAMERA SYSTEM
Applicant
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773 -4908
Applicant Contact LAURA D SENEFF
Correspondent
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773 -4908
Correspondent Contact LAURA D SENEFF
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/07/2003
Decision Date 06/04/2003
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
Predetermined Change
Control Plan Authorized		 No
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