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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 K820676
Device Name TOUCH FLUSH W/Y TRANSDUCER CONNECTOR
Applicant
Norton Performance Plastics Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Norton Performance Plastics Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2850
Classification Product Code
DRS  
Date Received03/11/1982
Decision Date 03/25/1982
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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