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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 K030469
Device Name LAPAROSHIELD CONDITIONED INSUFFLATION SET
Applicant
PALL MEDICAL
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
PALL MEDICAL
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number884.1730
Classification Product Code
HIF  
Date Received02/12/2003
Decision Date 05/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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