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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, powered (resuscitator)
510(k) Number K182956
Device Name Puffin Lite Infant Resuscitation System
Applicant
International Biomedical
8206 Cross Park Drive
Austin,  TX  78754
Applicant Contact Amy Pieper
Correspondent
International Biomedical
8206 Cross Park Drive
Austin,  TX  78754
Correspondent Contact Amy Pieper
Regulation Number868.5925
Classification Product Code
BTL  
Date Received10/24/2018
Decision Date 01/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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