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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Pneumoperitoneum, Simple
510(k) Number K910855
Device Name ENDOPATH VERESS NEEDLE
Applicant
Symbiosis Corp.
5801 Miami Lakes Dr.
Miami Lakes,  FL  33014
Applicant Contact KEVIN SMITH
Correspondent
Symbiosis Corp.
5801 Miami Lakes Dr.
Miami Lakes,  FL  33014
Correspondent Contact KEVIN SMITH
Regulation Number876.1500
Classification Product Code
FHP  
Date Received02/28/1991
Decision Date 04/18/1991
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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