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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K901530
Device Name WALLACE INTRAUTERINE INSEMINATION CATHETER
Applicant
Gynescope Corp.
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Applicant Contact KIP MARLOW
Correspondent
Gynescope Corp.
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Correspondent Contact KIP MARLOW
Regulation Number872.3060
Classification Product Code
EJT  
Date Received04/02/1990
Decision Date 07/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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