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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 K941381
Device Name HYGROBAC,S HYGROBOY AND HYGROBABY
Applicant
Mallinckrodt Medical
Hook Rd.
Argyle,  NY  12809
Applicant Contact JAMES C WEBBER
Correspondent
Mallinckrodt Medical
Hook Rd.
Argyle,  NY  12809
Correspondent Contact JAMES C WEBBER
Regulation Number868.5260
Classification Product Code
CAH  
Date Received03/22/1994
Decision Date 04/15/1994
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
Recalls CDRH Recalls
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