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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K853072
Device Name CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90
Applicant
Camino Laboratories, Inc.
5955 Pacific Center Blvd.
San Diego,  CA  92121
Applicant Contact DAN MCKAY
Correspondent
Camino Laboratories, Inc.
5955 Pacific Center Blvd.
San Diego,  CA  92121
Correspondent Contact DAN MCKAY
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/23/1985
Decision Date 12/09/1985
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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