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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Obstetric (And Accessories)
510(k) Number K903973
Device Name GARDOSI BIRTHING CUSHION
Applicant
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1274
Buffalo,  NY  14240
Applicant Contact ALBERT AMELOTTE
Correspondent
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1274
Buffalo,  NY  14240
Correspondent Contact ALBERT AMELOTTE
Regulation Number884.4900
Classification Product Code
KNC  
Date Received08/28/1990
Decision Date 09/27/1990
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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