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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 Cadwell,  NJ  07006
Applicant Contact ANNE M CESARIO
Correspondent
Schiff & Co.
1129 Bloomfield Ave.
West Cadwell,  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
Predetermined Change
Control Plan Authorized		 No
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