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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intravenous Extension Tubing Set
510(k) Number K873109
Device Name MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET
Applicant
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236
Applicant Contact COATS, M.D.
Correspondent
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236
Correspondent Contact COATS, M.D.
Regulation Number880.5440
Classification Product Code
OJA  
Date Received08/07/1987
Decision Date 08/28/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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