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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
510(k) Number K021996
Device Name BOLTON PTA CATHETER
Applicant
Bolton Medical, Inc.
16-00 Pollitt Dr.
Fair Lawn,  NJ  07410
Applicant Contact VIVIAN KELLY
Correspondent
Bolton Medical, Inc.
16-00 Pollitt Dr.
Fair Lawn,  NJ  07410
Correspondent Contact VIVIAN KELLY
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received06/18/2002
Decision Date 08/23/2002
Decision Substantially Equivalent (SESE)
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
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