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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 K936309
Device Name DELUXE MAGMAG BREAST PUMP
Applicant
Pigeon Corp.
5-1, Tomiyama-Cho, Kanda,
Chiyoda-Ku
Tokyo,  JP 101
Applicant Contact KENJI OMURA
Correspondent
Pigeon Corp.
5-1, Tomiyama-Cho, Kanda,
Chiyoda-Ku
Tokyo,  JP 101
Correspondent Contact KENJI OMURA
Regulation Number884.5160
Classification Product Code
HGX  
Date Received11/01/1993
Decision Date 11/30/1994
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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