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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 K931842
Device Name BREATHING FILTER
Applicant
Mag, Inc.
30 Robb Hill Rd.
Martinsville,  IN  46151
Applicant Contact JAMES BRASWELL
Correspondent
Mag, Inc.
30 Robb Hill Rd.
Martinsville,  IN  46151
Correspondent Contact JAMES BRASWELL
Regulation Number868.5260
Classification Product Code
CAH  
Date Received04/13/1993
Decision Date 05/19/1993
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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