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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 K933975
Device Name MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER SYSTEM
Applicant
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07436
Applicant Contact JANE AOYAGI
Correspondent
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07436
Correspondent Contact JANE AOYAGI
Regulation Number870.1250
Classification Product Code
LIT  
Date Received08/13/1993
Decision Date 10/06/1993
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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