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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 K002201
Device Name ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
Applicant
Sims Portex, Inc.
10 Bowman Dr.
Keene,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
Sims Portex, Inc.
10 Bowman Dr.
Keene,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number868.5260
Classification Product Code
CAH  
Date Received07/20/2000
Decision Date 02/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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