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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 K922571
Device Name INSTRUMENT, MANUAL, GENERAL SURGICAL
Applicant
SYMBIOSIS CORP.
8600 N.W. 41 ST.
MIAMI,  FL  33166
Applicant Contact KEVIN W SMITH
Correspondent
SYMBIOSIS CORP.
8600 N.W. 41 ST.
MIAMI,  FL  33166
Correspondent Contact KEVIN W SMITH
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/01/1992
Decision Date 08/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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