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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 K863880
Device Name BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.
Applicant
D.R.G. Scientific Industries
1140 Saratoga St.
East Boston,  MA  02128
Applicant Contact VINCENT E CORSANO
Correspondent
D.R.G. Scientific Industries
1140 Saratoga St.
East Boston,  MA  02128
Correspondent Contact VINCENT E CORSANO
Regulation Number862.1120
Classification Product Code
CHL  
Date Received10/06/1986
Decision Date 11/24/1986
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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