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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Drug Dose
510(k) Number K192841
Device Name InPen System
Applicant
Companion Medical, Inc.
11011 Via Frontera, Suite D
San Diego,  CA  92127
Applicant Contact Jasper Benke
Correspondent
Companion Medical, Inc.
11011 Via Frontera, Suite D
San Diego,  CA  92127
Correspondent Contact Jasper Benke
Regulation Number868.1890
Classification Product Code
NDC  
Subsequent Product Code
FMF  
Date Received10/03/2019
Decision Date 02/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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