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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, Manual (Resuscitator)
510(k) Number K902261
Device Name AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT
Applicant
AMBU, INC.
7476 NEW RIDGE RD-STE D
HANOVER,  MD  21076
Applicant Contact DAVID LEE
Correspondent
AMBU, INC.
7476 NEW RIDGE RD-STE D
HANOVER,  MD  21076
Correspondent Contact DAVID LEE
Regulation Number868.5915
Classification Product Code
BTM  
Date Received05/21/1990
Decision Date 07/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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