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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Suprapubic (And Accessories)
510(k) Number K881097
Device Name SPEC 5* SUPRAPUBIC CATHETER
Applicant
PORGES CORP.
56 WESTCOTT RD.
STAMFORD,  CT  06902
Applicant Contact CORNELIA DAMSKY
Correspondent
PORGES CORP.
56 WESTCOTT RD.
STAMFORD,  CT  06902
Correspondent Contact CORNELIA DAMSKY
Regulation Number876.5090
Classification Product Code
KOB  
Date Received03/15/1988
Decision Date 06/03/1988
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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