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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Timer, Apgar
510(k) Number K834129
Device Name MEDELA APGAR TIMER
Applicant
MEDELA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDELA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.2930
Classification Product Code
LHB  
Date Received11/30/1983
Decision Date 01/10/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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