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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Chamber, Patient Isolation
510(k) Number K896721
Device Name MODEL 7-AT TREATMENT CHAMBER
Applicant
J. H. Emerson Co.
22 Cottage Park Ave.
Cambridge,  MA  02140
Applicant Contact GEORGE P EMERSON
Correspondent
J. H. Emerson Co.
22 Cottage Park Ave.
Cambridge,  MA  02140
Correspondent Contact GEORGE P EMERSON
Regulation Number880.5450
Classification Product Code
LGM  
Date Received11/28/1989
Decision Date 01/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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