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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
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