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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 K901986
Device Name CO-OXIMETER CONTROLS
Applicant
Phoenix Diagnostics, Inc.
93 W. St.
Medfield,  MA  02052
Applicant Contact RAM NUNNA
Correspondent
Phoenix Diagnostics, Inc.
93 W. St.
Medfield,  MA  02052
Correspondent Contact RAM NUNNA
Regulation Number862.1660
Classification Product Code
JJS  
Date Received05/02/1990
Decision Date 05/31/1990
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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