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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 K884465
Device Name SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)
Applicant
Spirometrics, Inc.
33 Omni Circle
Auburn,  ME  04210 -1210
Applicant Contact G CYR
Correspondent
Spirometrics, Inc.
33 Omni Circle
Auburn,  ME  04210 -1210
Correspondent Contact G CYR
Regulation Number868.5260
Classification Product Code
CAH  
Date Received10/24/1988
Decision Date 11/09/1988
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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