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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K002839
Device Name END EXPIRATORY FILTER, MODEL RT020
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI,  NZ
Applicant Contact CHRIS MANDER
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI,  NZ
Correspondent Contact CHRIS MANDER
Regulation Number868.5260
Classification Product Code
CAH  
Date Received09/12/2000
Decision Date 10/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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