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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cholangiography
510(k) Number K903709
Device Name SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH
Applicant
Lifestream Int'L, Inc.
2828 N.Crescent River Dr.
The Woodlands,  TX  77381
Applicant Contact BRYAN E LYNCH
Correspondent
Lifestream Int'L, Inc.
2828 N.Crescent River Dr.
The Woodlands,  TX  77381
Correspondent Contact BRYAN E LYNCH
Regulation Number878.4200
Classification Product Code
GBZ  
Date Received08/16/1990
Decision Date 10/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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