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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K850753
Device Name NATURAL MOTHER BREAST PUMP
Applicant
Crystal Medical Products, Inc.
118 Barrington Commons Plz.
Suite 240
Barrington,  IL  60010
Applicant Contact WILLIAM J FRAIT
Correspondent
Crystal Medical Products, Inc.
118 Barrington Commons Plz.
Suite 240
Barrington,  IL  60010
Correspondent Contact WILLIAM J FRAIT
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/25/1985
Decision Date 06/07/1985
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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