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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, cystometric, hydraulic
510(k) Number K983325
Device Name IN-PROBE II URODYNAMIC SYSTEM
Applicant
INFLUENCE, INC.
71 STEVENSON ST., SUITE 1120
SAN FRANCISCO,  CA  94105
Applicant Contact PETER A BICK
Correspondent
INFLUENCE, INC.
71 STEVENSON ST., SUITE 1120
SAN FRANCISCO,  CA  94105
Correspondent Contact PETER A BICK
Regulation Number876.1620
Classification Product Code
FEN  
Date Received09/22/1998
Decision Date 11/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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