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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 K833536
Device Name PARTIAL PRESSURE ELECTRODE MEASUREMENT
Applicant
Shaban Mfg. Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Shaban Mfg. Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1120
Classification Product Code
CHL  
Date Received10/05/1983
Decision Date 12/29/1983
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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