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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 K952884
Device Name NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
Applicant
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07436
Applicant Contact STEPHGEN B ANDERSON
Correspondent
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07436
Correspondent Contact STEPHGEN B ANDERSON
Regulation Number870.1250
Classification Product Code
LIT  
Date Received06/23/1995
Decision Date 02/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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