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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cpb Check Valve, Retrograde Flow, In-Line
510(k) Number K960937
Device Name SUCTION SAFETY DEVICE
Applicant
R D Intl.
304 Arborcrest
Richardson,  TX  75080
Applicant Contact MIKE DAVIS
Correspondent
R D Intl.
304 Arborcrest
Richardson,  TX  75080
Correspondent Contact MIKE DAVIS
Regulation Number870.4400
Classification Product Code
MJJ  
Date Received03/08/1996
Decision Date 06/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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