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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cystometric gas (carbon-dioxide) on hydraulic device
510(k) Number K974775
Device Name SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE
Applicant
AIRTRONIC SERVICES, INC.
116 NORTH LIVELY BLVD.
ELK GROVE VILLAGE,  IL  60007
Applicant Contact ROBERT E WALTER
Correspondent
AIRTRONIC SERVICES, INC.
116 NORTH LIVELY BLVD.
ELK GROVE VILLAGE,  IL  60007
Correspondent Contact ROBERT E WALTER
Regulation Number876.1620
Classification Product Code
FAP  
Date Received12/22/1997
Decision Date 02/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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