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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K920331
Device Name RIGHT ATRIAL CATHETER KITS
Applicant
Akcess Medical Products, Inc.
201 N. Center Dr.
New Brunswick,  NJ  08902
Applicant Contact BALBIR KAPANY
Correspondent
Akcess Medical Products, Inc.
201 N. Center Dr.
New Brunswick,  NJ  08902
Correspondent Contact BALBIR KAPANY
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/23/1992
Decision Date 04/22/1992
Decision Substantially Equivalent - Kit (SESK)
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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