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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K870863
Device Name FNA THYROID BIOPSY KIT
Applicant
Flint Laboratories Div. Travenol
8800 Ellerbe Rd.
Post Office Box 6750
Shreveport,  LA  71136
Applicant Contact DAVID H WARNOCK,PHD
Correspondent
Flint Laboratories Div. Travenol
8800 Ellerbe Rd.
Post Office Box 6750
Shreveport,  LA  71136
Correspondent Contact DAVID H WARNOCK,PHD
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/03/1987
Decision Date 05/08/1987
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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