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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 K964584
Device Name AMBU SPUR NEONATE
Applicant
AMBU, INC.
611 N. HAMMONDS FERRY RD.
LINTHICUM,  MD  21090 -1356
Applicant Contact SANJAY H PARIKH
Correspondent
AMBU, INC.
611 N. HAMMONDS FERRY RD.
LINTHICUM,  MD  21090 -1356
Correspondent Contact SANJAY H PARIKH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received11/15/1996
Decision Date 05/15/1997
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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