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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Specimen, Sterile
510(k) Number K781557
Device Name 24-HOUR URINE COLLECTION COOLING WRAP
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 Number864.3250
Classification Product Code
FMH  
Date Received09/11/1978
Decision Date 10/17/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
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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