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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorbent, Carbon-Dioxide
510(k) Number K921803
Device Name SOFNOLIME CARBON DIOXIDE ABSORBENT
Applicant
Molecular Products , Ltd.
Mill End
Thaxted, Essex,  GB CM6 2LT
Applicant Contact CRICKMORE
Correspondent
Molecular Products , Ltd.
Mill End
Thaxted, Essex,  GB CM6 2LT
Correspondent Contact CRICKMORE
Regulation Number868.5300
Classification Product Code
CBL  
Date Received04/15/1992
Decision Date 10/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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