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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 K875077
Device Name HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.
Applicant
Herco Products, Inc.
P.O. Box 2903
Toledo,  OH  43606
Applicant Contact W. T WALTERS
Correspondent
Herco Products, Inc.
P.O. Box 2903
Toledo,  OH  43606
Correspondent Contact W. T WALTERS
Regulation Number868.5915
Classification Product Code
BTM  
Date Received12/09/1987
Decision Date 01/19/1988
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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