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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K850335
Device Name URETEROSCOPY CATHETER
Applicant
INMED CORP.
3030-B HOLCOMB BRIDGE RD.
NORCROSS,  GA  30071
Applicant Contact FLO BECKER
Correspondent
INMED CORP.
3030-B HOLCOMB BRIDGE RD.
NORCROSS,  GA  30071
Correspondent Contact FLO BECKER
Regulation Number876.5130
Classification Product Code
KOD  
Date Received01/28/1985
Decision Date 03/12/1985
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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