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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 K964848
Device Name WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM
Applicant
Marlow Surgical Technologies, Inc.
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Applicant Contact ARTHUR S GODDARD
Correspondent
Marlow Surgical Technologies, Inc.
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Correspondent Contact ARTHUR S GODDARD
Regulation Number884.5250
Classification Product Code
MFD  
Date Received12/03/1996
Decision Date 01/16/1997
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
Recalls CDRH Recalls
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