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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 K931259
Device Name ENDOSCOPIC OR THORASCOPIC FORCEPS
Applicant
T. KOROS SURGICAL INSTRUMENTS CORP.
610 FLINN AVE.
MOORPARK,  CA  93021
Applicant Contact GABRIEL KOROS
Correspondent
T. KOROS SURGICAL INSTRUMENTS CORP.
610 FLINN AVE.
MOORPARK,  CA  93021
Correspondent Contact GABRIEL KOROS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/12/1993
Decision Date 06/08/1993
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
Predetermined Change
Control Plan Authorized		 No
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