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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 K983604
Device Name INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER
Applicant
Washington Regulatory Services
23 Welisewitz Rd.
Ringoes,  NJ  08551
Applicant Contact RANDOLPH L COOKE
Correspondent
Washington Regulatory Services
23 Welisewitz Rd.
Ringoes,  NJ  08551
Correspondent Contact RANDOLPH L COOKE
Regulation Number884.6110
Classification Product Code
MQF  
Date Received10/14/1998
Decision Date 05/27/1999
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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