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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 K972283
Device Name SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT
Applicant
SIMS
5100 TICE ST.
FT. MYERS,  FL  33905
Applicant Contact AVIA TONEY
Correspondent
SIMS
5100 TICE ST.
FT. MYERS,  FL  33905
Correspondent Contact AVIA TONEY
Regulation Number868.5915
Classification Product Code
BTM  
Date Received06/19/1997
Decision Date 09/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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