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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K910218
Device Name LAPAROMED CHOLANGIOGRAM VACUUM DEVICE
Applicant
Laparomed Corp.
9272 Jeronimo Rd., Unit 109
Irvine,  CA  92718
Applicant Contact PAUL LUBOCK
Correspondent
Laparomed Corp.
9272 Jeronimo Rd., Unit 109
Irvine,  CA  92718
Correspondent Contact PAUL LUBOCK
Regulation Number880.6740
Classification Product Code
GCX  
Date Received01/17/1991
Decision Date 04/08/1991
Decision Substantially Equivalent (SESE)
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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