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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controls For Blood-Gases, (Assayed And Unassayed)
510(k) Number K955340
Device Name EUROTROL GAS - ISE CONTROL
Applicant
Direct Solutions
7 Hayrick Ln.
P.O. Box 900
Westford,  MA  01886
Applicant Contact WILLIAM R DONOHUE
Correspondent
Direct Solutions
7 Hayrick Ln.
P.O. Box 900
Westford,  MA  01886
Correspondent Contact WILLIAM R DONOHUE
Regulation Number862.1660
Classification Product Code
JJS  
Date Received11/20/1995
Decision Date 12/26/1995
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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