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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 K861513
Device Name LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP
Applicant
CRYSTAL MEDICAL PRODUCTS, INC.
118 BARRINGTON COMMONS PLAZA
SUITE 240
BARRINGTON,  IL  60010
Applicant Contact FRAIT, JR
Correspondent
CRYSTAL MEDICAL PRODUCTS, INC.
118 BARRINGTON COMMONS PLAZA
SUITE 240
BARRINGTON,  IL  60010
Correspondent Contact FRAIT, JR
Regulation Number884.5160
Classification Product Code
HGX  
Date Received04/23/1986
Decision Date 08/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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