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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K990509
Device Name OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
Applicant
Implemed, Inc.
313 Pleasant St.
Watertown,  MA  02172
Applicant Contact ANTHONY L BLANK
Correspondent
Implemed, Inc.
313 Pleasant St.
Watertown,  MA  02172
Correspondent Contact ANTHONY L BLANK
Regulation Number876.5130
Classification Product Code
EZL  
Date Received02/18/1999
Decision Date 05/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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