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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 K851070
Device Name RESP-BAC BACTERIA FILTER
Applicant
Medicomp, Inc.
411 Freemont St.
Anoka,  MN  55303
Applicant Contact PAUL ENGLAND
Correspondent
Medicomp, Inc.
411 Freemont St.
Anoka,  MN  55303
Correspondent Contact PAUL ENGLAND
Regulation Number868.5260
Classification Product Code
CAH  
Date Received03/18/1985
Decision Date 06/14/1985
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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