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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K810637
Device Name COBE DISPOSABLE PRESSURE TRANSDUCER
Applicant
Cobe Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Applicant Contact None None
Correspondent
Cobe Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent Contact none none
Regulation Number870.2850
Classification Product Code
DRS  
Date Received03/10/1981
Decision Date 04/23/1981
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
Recalls CDRH Recalls
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