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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Cardiac, External
510(k) Number K792458
Device Name PNEUPAC TEST SET, PT.#500-A250
Applicant
Pneupac , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Pneupac , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.5200
Classification Product Code
DRM  
Date Received12/03/1979
Decision Date 02/05/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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