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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, disposable
510(k) Number K922614
Device Name TURKEL THORACENTESIS SYSTEM
Applicant
SYMBIOSIS CORP.
8600 N.W. 41 ST.
MIAMI,  FL  33166
Applicant Contact KEVIN SMITH
Correspondent
SYMBIOSIS CORP.
8600 N.W. 41 ST.
MIAMI,  FL  33166
Correspondent Contact KEVIN SMITH
Regulation Number878.4800
Classification Product Code
GAA  
Date Received06/02/1992
Decision Date 07/30/1992
Decision Substantially Equivalent (SESE)
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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