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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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