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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Defoamer, Cardiopulmonary Bypass
510(k) Number K842373
Device Name VENOUS RESERVOIR-BMR-1500-HARD SHELL
Applicant
American Bentley
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact DONALD A RAIBLE
Correspondent
American Bentley
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact DONALD A RAIBLE
Regulation Number870.4230
Classification Product Code
DTP  
Date Received06/15/1984
Decision Date 12/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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