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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 K181327
Device Name InPen Dose Calculator
Applicant
Companion Medical, Inc.
16486 Bernardo Center Drive, # 300
San Diego,  CA  92128
Applicant Contact Jasper Benke
Correspondent
Companion Medical, Inc.
16486 Bernardo Center Drive, # 300
San Diego,  CA  92128
Correspondent Contact Jasper Benke
Regulation Number868.1890
Classification Product Code
NDC  
Date Received05/18/2018
Decision Date 07/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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