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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 K884327
Device Name EXCEL Y-CONNECTOR CAT. #E-201
Applicant
Medical Profiles, Inc.
13324 Farmington Rd.
Lavonia,  MI  48150
Applicant Contact BONE, II
Correspondent
Medical Profiles, Inc.
13324 Farmington Rd.
Lavonia,  MI  48150
Correspondent Contact BONE, II
Regulation Number870.1250
Classification Product Code
LIT  
Date Received10/14/1988
Decision Date 04/19/1989
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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