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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 K952214
Device Name SIMS INTERTECH HYPERINFLATION BAG SYSTEM
Applicant
Intertech Resources, Inc.
5100 Tice St.
Fort Myers,  FL  33905
Applicant Contact AVIA TONEY
Correspondent
Intertech Resources, Inc.
5100 Tice St.
Fort Myers,  FL  33905
Correspondent Contact AVIA TONEY
Regulation Number868.5905
Classification Product Code
NHK  
Date Received05/11/1995
Decision Date 06/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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