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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 K001386
Device Name ACCUSET SENSOR, MODEL 2000
Applicant
Pelvicare, Inc.
28202 Cabot Rd., Suite 300
Laguna Niguel,  CA  92677
Applicant Contact WALTER D WALLACH
Correspondent
Pelvicare, Inc.
28202 Cabot Rd., Suite 300
Laguna Niguel,  CA  92677
Correspondent Contact WALTER D WALLACH
Regulation Number876.1620
Classification Product Code
FEN  
Subsequent Product Code
HIR  
Date Received05/02/2000
Decision Date 07/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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