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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
2804 Albany Court
Fairfax,  VA  22031
Applicant Contact Diane Miller
Ultra LifeScience Solutions Inc.
872 S. Milwaukee Avenue, #286
Libertyville,  IL  60048
Correspondent Contact Chris Henza
Regulation Number868.5320
Classification Product Code
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