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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Intrauterine Insemination
510(k) Number K970750
Device Name MICROSPAN INSEMINATION SYSTEM
Applicant
Imagyn Medical, Inc.
27651 La Paz Rd.
Laguna Niguel,  CA  92656
Applicant Contact DEBRA A RINDERER
Correspondent
Imagyn Medical, Inc.
27651 La Paz Rd.
Laguna Niguel,  CA  92656
Correspondent Contact DEBRA A RINDERER
Regulation Number884.5250
Classification Product Code
MFD  
Date Received03/03/1997
Decision Date 05/05/1997
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
Predetermined Change
Control Plan Authorized		 No
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