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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
510(k) Number K050857
Device Name BIB PTA BALLOON CATHETER
Applicant
NuMED, Inc.
2880 Main St.
Hopkinton,  NY  12965
Applicant Contact JODI GIJANTO
Correspondent
NuMED, Inc.
2880 Main St.
Hopkinton,  NY  12965
Correspondent Contact JODI GIJANTO
Regulation Number870.1250
Classification Product Code
NVM  
Date Received04/05/2005
Decision Date 07/28/2005
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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