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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Jelly, Lubricating, For Transurethral Surgical Instrument
510(k) Number K951713
Device Name BUTTON LUBRICATOR
Applicant
Fibertech Instruments, Inc.
5020 Campbell Blvd., Suite K
Baltimore,  MD  21236
Applicant Contact FRANK MAJEROWICZ
Correspondent
Fibertech Instruments, Inc.
5020 Campbell Blvd., Suite K
Baltimore,  MD  21236
Correspondent Contact FRANK MAJEROWICZ
Regulation Number876.1500
Classification Product Code
FHX  
Date Received04/14/1995
Decision Date 04/25/1995
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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