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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Uterine
510(k) Number K944238
Device Name ENDOCYTE TM
Applicant
D.L. Nelson and Assoc., Inc.
2902 Marlin Cir.
Atlanta,  GA  30341
Applicant Contact DENNIS L NELSON
Correspondent
D.L. Nelson and Assoc., Inc.
2902 Marlin Cir.
Atlanta,  GA  30341
Correspondent Contact DENNIS L NELSON
Regulation Number884.4530
Classification Product Code
HCY  
Date Received08/31/1994
Decision Date 09/15/1995
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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