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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 K936248
Device Name MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES, VERRES INSUFFLATION NEEDLES AND HOLDERS
Applicant
MEDICON INSTRUMENTS, INC.
COLUBMIA SQUARE
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Applicant Contact HOWARD M MHOLSTEIN
Correspondent
MEDICON INSTRUMENTS, INC.
COLUBMIA SQUARE
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Correspondent Contact HOWARD M MHOLSTEIN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/30/1993
Decision Date 05/16/1994
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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