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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 K925462
Device Name BREATHING FILTERS 1942T/1941T/2014T
Applicant
Intersurgical, Inc.
P.O. Box 642
Carriage Ln. Pl.
Cazenovia,  NY  13035
Applicant Contact ALAN I BECKER
Correspondent
Intersurgical, Inc.
P.O. Box 642
Carriage Ln. Pl.
Cazenovia,  NY  13035
Correspondent Contact ALAN I BECKER
Regulation Number868.5260
Classification Product Code
CAH  
Date Received10/29/1992
Decision Date 05/21/1993
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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