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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 K992308
Device Name OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
Applicant
LIFETEK MEDICAL, INC.
P.O. BOX 560
STILLWATER,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
LIFETEK MEDICAL, INC.
P.O. BOX 560
STILLWATER,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number884.6100
Classification Product Code
MQE  
Date Received07/09/1999
Decision Date 09/13/1999
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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