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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K855176
Device Name TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS
Applicant
Urologic Surgical Devices Corp.
343 S. Dearborn St.
Suite 602
Chicago,  IL  60604
Applicant Contact HAROLD E COLLINS
Correspondent
Urologic Surgical Devices Corp.
343 S. Dearborn St.
Suite 602
Chicago,  IL  60604
Correspondent Contact HAROLD E COLLINS
Regulation Number876.1500
Classification Product Code
FBK  
Subsequent Product Codes
FAS   IWJ   KNW  
Date Received12/26/1985
Decision Date 05/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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