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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier And Signal Conditioner, Transducer Signal
510(k) Number K803011
Device Name DISPOSABLE DIAPHRAGM DONE
Applicant
Sorensen Research
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sorensen Research
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2060
Classification Product Code
DRQ  
Date Received11/28/1980
Decision Date 12/31/1980
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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