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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Blood, Non-Electromagnetic Radiation
510(k) Number K770232
Device Name BLOOD/FLUID WARMER MODEL DW-1000A
Applicant
GORMAN RUPP INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GORMAN RUPP INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.9205
Classification Product Code
BSB  
Date Received02/07/1977
Decision Date 02/14/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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