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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 K895169
Device Name MANUAL DISPOSABLE PULMONARY RESUSCITATOR
Applicant
F.L.W. Plastics, Inc.
4920 N. Warren Dr.
Columbus,  IN  47203
Applicant Contact TIMOTHY D STRUTHERS
Correspondent
F.L.W. Plastics, Inc.
4920 N. Warren Dr.
Columbus,  IN  47203
Correspondent Contact TIMOTHY D STRUTHERS
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/10/1989
Decision Date 10/13/1989
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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