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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Subclavian
510(k) Number K920634
Device Name SPLITTABLE SHEATH INTRODUCER SET
Applicant
Akcess Medical Products, Inc.
201 N. Center Dr.
New Brunswick,  NJ  08902
Applicant Contact BALIR B KAPANY
Correspondent
Akcess Medical Products, Inc.
201 N. Center Dr.
New Brunswick,  NJ  08902
Correspondent Contact BALIR B KAPANY
Regulation Number876.5540
Classification Product Code
LFJ  
Date Received02/12/1992
Decision Date 01/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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