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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 K834299
Device Name LONG TERM CENTRAL VENOUS ACCESS CATH
Applicant
Burron Medical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Burron Medical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5970
Classification Product Code
LJS  
Date Received12/08/1983
Decision Date 05/01/1984
Decision Substantially Equivalent (SESE)
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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