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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K855108
Device Name RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR
Applicant
Biomaterials International, Inc.
P.O. Box 8852, Research Park
420 Chipeta Way, Suite 160
Salt Lake City,  UT  84108
Applicant Contact COLEMAN PH.D.
Correspondent
Biomaterials International, Inc.
P.O. Box 8852, Research Park
420 Chipeta Way, Suite 160
Salt Lake City,  UT  84108
Correspondent Contact COLEMAN PH.D.
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received12/23/1985
Decision Date 02/21/1986
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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