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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filiform And Filiform Follower
510(k) Number K912839
Device Name LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE
Applicant
Baxter Healthcare Corp
2132 Michelson Dr.
Irvine,  CA  92715
Applicant Contact CAROLE E MARCOT
Correspondent
Baxter Healthcare Corp
2132 Michelson Dr.
Irvine,  CA  92715
Correspondent Contact CAROLE E MARCOT
Regulation Number876.5520
Classification Product Code
FBW  
Date Received06/26/1991
Decision Date 09/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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