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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bag, Reservoir
510(k) Number K181424
Device Name PeDIA
Applicant
Pedia, LLC
2804 Albany Ct.
Fairfax,  VA  22031
Applicant Contact Diane Miller
Correspondent
Ultra Life Science Solutions, Inc.
872 S. Milwaukee Ave. #286
Libertyville,  IL  60048
Correspondent Contact Chris Henza
Regulation Number868.5320
Classification Product Code
BTC  
Date Received05/31/2018
Decision Date 09/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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