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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 K901816
Device Name PRESSURE TUBING AND ACCESSORIES
Applicant
Arbo Medical, Inc.
3728 Plz. Dr.
Ann Arbor,  MI  48108
Applicant Contact DAWN I MOORE
Correspondent
Arbo Medical, Inc.
3728 Plz. Dr.
Ann Arbor,  MI  48108
Correspondent Contact DAWN I MOORE
Regulation Number868.5260
Classification Product Code
CAH  
Date Received04/23/1990
Decision Date 07/12/1990
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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