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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Electric
510(k) Number K910964
Device Name HOT BIOPSY FORCEPS
Applicant
SYMBIOSIS CORP.
5801 MIAMI LAKES DR.
MIAMI LAKES,  FL  33014
Applicant Contact KEVIN W SMITH
Correspondent
SYMBIOSIS CORP.
5801 MIAMI LAKES DR.
MIAMI LAKES,  FL  33014
Correspondent Contact KEVIN W SMITH
Regulation Number876.4300
Classification Product Code
KGE  
Date Received03/06/1991
Decision Date 05/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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