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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K892501
Device Name WRIGHT MEDICAL FETASAFE
Applicant
Wright Medical Corp.
11023 118th Pl. NE
Kirkland,  WA  98033
Applicant Contact BERT E COATES
Correspondent
Wright Medical Corp.
11023 118th Pl. NE
Kirkland,  WA  98033
Correspondent Contact BERT E COATES
Regulation Number884.2740
Classification Product Code
HGM  
Date Received04/05/1989
Decision Date 09/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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