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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 K913474
Device Name RESPIRE DISPOSABLE PULMONARY RESUSCITATOR
Applicant
Med-Tek Innovations, Inc.
1223 S. 23 St.
Milwaukee,  WI  53204
Applicant Contact ALAN E WHITMARSH
Correspondent
Med-Tek Innovations, Inc.
1223 S. 23 St.
Milwaukee,  WI  53204
Correspondent Contact ALAN E WHITMARSH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/05/1991
Decision Date 02/03/1993
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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