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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Endometrial
510(k) Number K843941
Device Name ENDOCYTE
Applicant
Gyneco, Inc.
12 Minneakoning Rd.
Flemington,  NJ  08822
Applicant Contact JEANINE C VIGEANT
Correspondent
Gyneco, Inc.
12 Minneakoning Rd.
Flemington,  NJ  08822
Correspondent Contact JEANINE C VIGEANT
Regulation Number884.1100
Classification Product Code
HFE  
Date Received10/09/1984
Decision Date 02/25/1985
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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