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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspirator, Endometrial
510(k) Number K903002
Device Name PROBET (TM)
Applicant
GYNOPHARMA, INC.
C/O ELLIS PHARM CONSULTING INC
913 STATE ROAD
PRINCETON,  NJ  08540
Applicant Contact LEVI ELLIS
Correspondent
GYNOPHARMA, INC.
C/O ELLIS PHARM CONSULTING INC
913 STATE ROAD
PRINCETON,  NJ  08540
Correspondent Contact LEVI ELLIS
Regulation Number884.1060
Classification Product Code
HFF  
Date Received07/09/1990
Decision Date 04/05/1991
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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