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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Biliary Mechanical
510(k) Number K905552
Device Name LAPAROLITH
Applicant
Baxter Healthcare Corp
2132 Michelson Dr.
Irvine,  CA  92715
Applicant Contact WAYNE R HOHMAN
Correspondent
Baxter Healthcare Corp
2132 Michelson Dr.
Irvine,  CA  92715
Correspondent Contact WAYNE R HOHMAN
Regulation Number876.4500
Classification Product Code
LQC  
Date Received12/11/1990
Decision Date 12/17/1991
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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