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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K904379
Device Name SURGICAL TROCAR AND CANNULA
Applicant
Applied Vascular Devices, Inc.
26051 Merit Cir., #104
Laguna Hills,  CA  92653
Applicant Contact JO STEGWELL
Correspondent
Applied Vascular Devices, Inc.
26051 Merit Cir., #104
Laguna Hills,  CA  92653
Correspondent Contact JO STEGWELL
Regulation Number884.1720
Classification Product Code
HET  
Date Received09/25/1990
Decision Date 12/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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