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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 K023793
Device Name 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
Applicant
PORTEX, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Applicant Contact CINDY ENGELHARDT
Correspondent
PORTEX, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Correspondent Contact CINDY ENGELHARDT
Regulation Number868.5915
Classification Product Code
BTM  
Date Received11/13/2002
Decision Date 02/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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