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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 K936115
Device Name CAT-600 PENILE PLETHYSMOGRAPH
Applicant
Farrall Instruments, Inc.
3724 Arch Ave.
Grand Island,  NE  68803
Applicant Contact WILLIAM R FARRALL
Correspondent
Farrall Instruments, Inc.
3724 Arch Ave.
Grand Island,  NE  68803
Correspondent Contact WILLIAM R FARRALL
Classification Product Code
LIL  
Date Received02/19/1993
Decision Date 01/10/1995
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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