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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, External Body, Negative Pressure, Adult (Cuirass)
510(k) Number K894649
Device Name EMERSON 33-CR CHEST RESPIRATOR
Applicant
Emerson Intl. Co.
22 Cottage Park Ave.
Cambridge,  MA  02140
Applicant Contact GEORGE EMERSON
Correspondent
Emerson Intl. Co.
22 Cottage Park Ave.
Cambridge,  MA  02140
Correspondent Contact GEORGE EMERSON
Regulation Number868.5935
Classification Product Code
BYT  
Date Received07/24/1989
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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