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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pneumoperitoneum Needle
510(k) Number K942484
Device Name VERRES NEEDLE
Applicant
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact CAROL A WEIDEMAN, PH.D.
Correspondent
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact CAROL A WEIDEMAN, PH.D.
Regulation Number876.1500
Classification Product Code
FHO  
Date Received05/25/1994
Decision Date 06/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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