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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 K000997
Device Name ZORTRAN DETECTOR
Applicant
LUCENT MEDICAL SYSTEMS
135 LAKE ST. SOUTH
# 250
KIRKLAND,  WA  98033
Applicant Contact CINDY PESTKA
Correspondent
LUCENT MEDICAL SYSTEMS
135 LAKE ST. SOUTH
# 250
KIRKLAND,  WA  98033
Correspondent Contact CINDY PESTKA
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/28/2000
Decision Date 09/07/2000
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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