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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hematocrit, Tube, Rack, Sealer, Holder
510(k) Number K881186
Device Name MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL
Applicant
Helps Products, Inc.
4469 Sw35th.St.
Orlando,  FL  32811
Applicant Contact BRIAN LEMAY
Correspondent
Helps Products, Inc.
4469 Sw35th.St.
Orlando,  FL  32811
Correspondent Contact BRIAN LEMAY
Regulation Number864.6400
Classification Product Code
GHY  
Date Received03/21/1988
Decision Date 05/13/1988
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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