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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Abortion Unit, Vacuum
510(k) Number K883283
Device Name DISPOSABLE AMNIOTOME
Applicant
Galenica Enterprises, Inc.
C.P. 13
Ste-Therese
Quebec Canada J7e 4h7,  CA
Applicant Contact JACQUES R MARCOTTE
Correspondent
Galenica Enterprises, Inc.
C.P. 13
Ste-Therese
Quebec Canada J7e 4h7,  CA
Correspondent Contact JACQUES R MARCOTTE
Regulation Number884.5070
Classification Product Code
HGG  
Date Received08/04/1988
Decision Date 10/18/1988
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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