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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name meter, peak flow, spirometry
510(k) Number K010009
Device Name KOKO PEAK KP; KOKO PEAK KP+
Applicant
PDS HEALTHCARE PRODUCTS, INC.
908 MAIN ST.
LOUISVILE,  CO  80027
Applicant Contact CHERYL RAILSBACK
Correspondent
PDS HEALTHCARE PRODUCTS, INC.
908 MAIN ST.
LOUISVILE,  CO  80027
Correspondent Contact CHERYL RAILSBACK
Regulation Number868.1860
Classification Product Code
BZH  
Date Received01/02/2001
Decision Date 06/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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