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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K832579
Device Name PHYSIOLOGICAL PRESS. MEASUREMENT CATH
Applicant
Camino Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Camino Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2870
Classification Product Code
DXO  
Date Received08/02/1983
Decision Date 10/20/1983
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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