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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Assisted Reproduction
510(k) Number K992307
Device Name EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER
Applicant
Fertility Technology Resources, Inc.
4343 Shallowford Rd.
Suite D-4
Marietta,  GA  30062
Correspondent
Fertility Technology Resources, Inc.
4343 Shallowford Rd.
Suite D-4
Marietta,  GA  30062
Regulation Number884.6110
Classification Product Code
MQF  
Date Received07/09/1999
Decision Date 09/13/1999
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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