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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calculator, predicted values, pulmonary function
510(k) Number K780584
Device Name PULMONARY FUNCTION TESTER
Applicant
WARREN E. COLLINS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
WARREN E. COLLINS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1890
Classification Product Code
BTY  
Date Received04/11/1978
Decision Date 05/16/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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