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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, irrigation
510(k) Number K926109
Device Name FLUID DRAINAGE TRAY
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 Number878.4200
Classification Product Code
GBX  
Date Received12/03/1992
Decision Date 06/07/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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