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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 -5118
Applicant Contact DENNIS L NELSON
Correspondent
D.L. NELSON AND ASSOC., INC.
2902 MARLIN CIR.
ATLANTA,  GA  30341 -5118
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
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