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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K033991
Device Name MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
Applicant
Pall Medical
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Pall Medical
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/23/2003
Decision Date 01/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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