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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K812173
Device Name FLUSHFLO II
Applicant
Bentley Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bentley Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1210
Classification Product Code
KRA  
Date Received08/03/1981
Decision Date 08/18/1981
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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