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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Collection, Capillary Blood
510(k) Number K881187
Device Name NATELSON TUBES, HEPARIN AND PLAIN
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 Number864.6150
Classification Product Code
GIO  
Date Received03/21/1988
Decision Date 05/06/1988
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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