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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K922190
Device Name LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
Applicant
Advanced Surgical, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Applicant Contact HARRIET SCHWATZMAN
Correspondent
Advanced Surgical, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Correspondent Contact HARRIET SCHWATZMAN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/11/1992
Decision Date 10/23/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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