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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K882585
Device Name CAVROLAB
Applicant
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236
Applicant Contact COATS, MD
Correspondent
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236
Correspondent Contact COATS, MD
Regulation Number892.1550
Classification Product Code
IYN  
Date Received06/22/1988
Decision Date 03/02/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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