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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K930787
Device Name LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT
Applicant
Advanced Surgical, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Applicant Contact ANGELIQUE ANDERSON
Correspondent
Advanced Surgical, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Correspondent Contact ANGELIQUE ANDERSON
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
GBZ  
Date Received02/16/1993
Decision Date 07/09/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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