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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Positive Pressure Breathing, Intermittent
510(k) Number K002598
Device Name EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING
Applicant
J. H. Emerson Co.
22 Cottage Park Ave.
Cambridge,  MA  02140
Applicant Contact GEORGE EMERSON
Correspondent
J. H. Emerson Co.
22 Cottage Park Ave.
Cambridge,  MA  02140
Correspondent Contact GEORGE EMERSON
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received08/21/2000
Decision Date 11/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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