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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 K923661
Device Name QUADRASORB FILTER
Applicant
UNION BROACH, DIV. MOYCO INDUSTRIES, INC.
P.O. BOX 508
ABERDEEN ROAD
EMIGSVILLE,  PA  17318
Applicant Contact LONNIE M GRAYBILL
Correspondent
UNION BROACH, DIV. MOYCO INDUSTRIES, INC.
P.O. BOX 508
ABERDEEN ROAD
EMIGSVILLE,  PA  17318
Correspondent Contact LONNIE M GRAYBILL
Regulation Number868.5260
Classification Product Code
CAH  
Date Received07/22/1992
Decision Date 10/20/1992
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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