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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 K992057
Device Name IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
Applicant
SIMS PORTEX, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
SIMS PORTEX, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number868.5915
Classification Product Code
BTM  
Date Received06/18/1999
Decision Date 09/13/1999
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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