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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 K984306
Device Name `THE INSEMINATOR' (PROPOSED)
Applicant
Wallach Surgical Devices, Inc.
235 Edison Rd.
Orange,  CT  06477
Applicant Contact MICHAEL MALIS
Correspondent
Wallach Surgical Devices, Inc.
235 Edison Rd.
Orange,  CT  06477
Correspondent Contact MICHAEL MALIS
Regulation Number884.5250
Classification Product Code
MFD  
Date Received12/02/1998
Decision Date 03/01/1999
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
Predetermined Change
Control Plan Authorized		 No
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