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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, assisted reproduction
510(k) Number K191291
Device Name Wallace Dual Lumen Oocyte Recovery System
CooperSurgical, Inc.
95 Corporate Drive
trumbull,  CT  06611
Applicant Contact christine kupchick
CooperSurgical, Inc.
95 Corporate Drive
trumbull,  CT  06611
Correspondent Contact christine kupchick
Regulation Number884.6100
Classification Product Code
Date Received05/14/2019
Decision Date 06/12/2019
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