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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resuscitator, Manual, Non Self-Inflating
510(k) Number K970785
Device Name SIMS HYPERINFLATION BAG SYSTEM
Applicant
Sims
5100 Tice St.
Fort Myers,  FL  33905
Applicant Contact AVIA TONEY
Correspondent
Sims
5100 Tice St.
Fort Myers,  FL  33905
Correspondent Contact AVIA TONEY
Regulation Number868.5905
Classification Product Code
NHK  
Date Received03/04/1997
Decision Date 06/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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