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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, Non-Powered
510(k) Number K850242
Device Name CRYSTAL MANUAL 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 Number884.5150
Classification Product Code
HGY  
Date Received01/22/1985
Decision Date 02/25/1985
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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