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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K030117
Device Name ENHANCE SPERM FREEZE
Applicant
Conception Technology, Inc.
3722 Ave. Sausalito
Irvine,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
Conception Technology, Inc.
3722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number884.6180
Classification Product Code
MQL  
Date Received01/13/2003
Decision Date 03/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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