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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 -1691
Applicant Contact GEORGE EMERSON
Correspondent
J. H. EMERSON CO.
22 COTTAGE PARK AVE.
CAMBRIDGE,  MA  02140 -1691
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
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