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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Rectal
510(k) Number K890466
Device Name SIGMOID TONOMITOR
Applicant
Tonometrics, Inc.
4903 Sangamore Rd.
Bethesda,  MD  20816
Applicant Contact L MACKEEN,PHD
Correspondent
Tonometrics, Inc.
4903 Sangamore Rd.
Bethesda,  MD  20816
Correspondent Contact L MACKEEN,PHD
Regulation Number876.5980
Classification Product Code
GBT  
Date Received01/31/1989
Decision Date 04/21/1989
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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