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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 K980627
FOIA Releasable 510(k) K980627
Device Name NEVA SYSTEM
Applicant
Urometrics, Inc.
445 Etna St., Suite 56
St. Paul,  MN  55106
Applicant Contact PHILIP A MESSINA
Correspondent
Urometrics, Inc.
445 Etna St., Suite 56
St. Paul,  MN  55106
Correspondent Contact PHILIP A MESSINA
Classification Product Code
LIL  
Date Received02/18/1998
Decision Date 04/07/1998
Decision Substantially Equivalent (SESE)
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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