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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K912979
Device Name HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
Applicant
Labeltape Meditect, Inc.
4275 Airwest Dr., SE
P.O. Box 8823
Grand Rapids,  MI  49508
Applicant Contact LORA L JONES
Correspondent
Labeltape Meditect, Inc.
4275 Airwest Dr., SE
P.O. Box 8823
Grand Rapids,  MI  49508
Correspondent Contact LORA L JONES
Regulation Number864.6550
Classification Product Code
KHE  
Date Received06/03/1991
Decision Date 10/04/1991
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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