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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauge, Pressure, Coronary, Cardiopulmonary Bypass
510(k) Number K820912
Device Name PMS-2 PRESSURE MONITOR SEPARATOR
Applicant
DELTA MEDICAL INDUSTRIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DELTA MEDICAL INDUSTRIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.4310
Classification Product Code
DXS  
Date Received04/01/1982
Decision Date 05/18/1982
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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