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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Penile Tumescence
510(k) Number K831252
Device Name TUMISTORE RECORDER 1311
Applicant
Life-Tech Intl., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Life-Tech Intl., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
LIL  
Date Received04/18/1983
Decision Date 05/18/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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