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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Obstetrical, Ac-Powered (And Accessories)
510(k) Number K770438
Device Name CART, PROCEDURES
Applicant
I E INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
I E INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.4900
Classification Product Code
HDD  
Date Received03/07/1977
Decision Date 07/01/1977
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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