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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K894419
Device Name GASTRO ENTEROLOGICAL BIOPTOME
Applicant
Symbiosis Corp.
8600 NW 41 St.
Miami,  FL  33166
Applicant Contact KEVIN W SMITH
Correspondent
Symbiosis Corp.
8600 NW 41 St.
Miami,  FL  33166
Correspondent Contact KEVIN W SMITH
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/17/1989
Decision Date 09/08/1989
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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