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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 K810065
Device Name SCOTT CM42 PASTEURIZER
Applicant
William Harvey Life Products Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
William Harvey Life Products Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.5160
Classification Product Code
HGX  
Date Received01/13/1981
Decision Date 01/28/1981
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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