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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 K973106
Device Name GOLEMB DISPOSABLE BAG MASK RESUSCITATOR
Applicant
Allied Healthcare Products, Inc.
1720 Sublette Ave.
Saint Louis,  MO  63110
Applicant Contact VERNON TRIMBLE
Correspondent
Allied Healthcare Products, Inc.
1720 Sublette Ave.
Saint Louis,  MO  63110
Correspondent Contact VERNON TRIMBLE
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/19/1997
Decision Date 01/29/1998
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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