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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Heating
510(k) Number K790549
Device Name HEATING BLOCK, WAMPOLE 37 C
Applicant
Armkel, LLC
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Armkel, LLC
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2050
Classification Product Code
JRG  
Date Received03/20/1979
Decision Date 05/03/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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