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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Infant Radiant
510(k) Number K813408
Device Name SAGE 2200 STERILE SPECIMEN CONTAINER
Applicant
SAGE PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SAGE PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5130
Classification Product Code
FMT  
Date Received12/07/1981
Decision Date 01/25/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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