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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(k) Number K881188
Device Name BLOOD PH CAPILLARY TUBES, HEPARIN
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 Number862.1120
Classification Product Code
CHL  
Date Received03/21/1988
Decision Date 07/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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