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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 K014115
Device Name 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
Applicant
PORTEX, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
PORTEX, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number868.5915
Classification Product Code
BTM  
Date Received12/14/2001
Decision Date 02/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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