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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 K974141
Device Name PLUS REUSABLE RESUSCITATOR
Applicant
SCHIFF & CO.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Applicant Contact ANNE M CESARIO
Correspondent
SCHIFF & CO.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Correspondent Contact ANNE M CESARIO
Regulation Number868.5915
Classification Product Code
BTM  
Date Received11/03/1997
Decision Date 05/21/1998
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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