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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 K880394
Device Name FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR
Applicant
INTERTECH/OHIO
5030 TICE ST.
FORT MYERS,  FL  33905
Applicant Contact JAMES W POPE
Correspondent
INTERTECH/OHIO
5030 TICE ST.
FORT MYERS,  FL  33905
Correspondent Contact JAMES W POPE
Regulation Number868.5915
Classification Product Code
BTM  
Date Received01/29/1988
Decision Date 02/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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