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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K930630
Device Name RIGHT ATRIAL CATHETER
Applicant
AKCESS MEDICAL PRODUCTS, INC.
201 NORTH CENTER DR.
NEW BRUNSWICK,  NJ  08902
Applicant Contact BALBIR B KAPANY
Correspondent
AKCESS MEDICAL PRODUCTS, INC.
201 NORTH CENTER DR.
NEW BRUNSWICK,  NJ  08902
Correspondent Contact BALBIR B KAPANY
Regulation Number880.5970
Classification Product Code
LJS  
Date Received02/08/1993
Decision Date 02/07/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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