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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, Short-Term Less Than 30 Days
510(k) Number K895191
Device Name ANTI-THROMBOGENIC COATING FOR CATHETERS
Applicant
Burron Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact PEGGY KEIFFER
Correspondent
Burron Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact PEGGY KEIFFER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/11/1989
Decision Date 11/24/1989
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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