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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngoscope, Endoscope
510(k) Number K021747
Device Name DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR
Applicant
SURGICON, INC.
400 LONG BEACH BLVD.
STRATFORD,  CT  06615
Applicant Contact CURTIS RAYMOND
Correspondent
SURGICON, INC.
400 LONG BEACH BLVD.
STRATFORD,  CT  06615
Correspondent Contact CURTIS RAYMOND
Regulation Number876.1500
Classification Product Code
GCI  
Date Received05/28/2002
Decision Date 08/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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