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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy, Suction
510(k) Number K902910
Device Name CYTOASPIRATOR
Applicant
H & B MEDICAL TECHNOLOGY, INC.
2001 PRIESTLEY AVE.
NORMAN,  OK  73069
Applicant Contact P HEMSTREET
Correspondent
H & B MEDICAL TECHNOLOGY, INC.
2001 PRIESTLEY AVE.
NORMAN,  OK  73069
Correspondent Contact P HEMSTREET
Regulation Number876.1075
Classification Product Code
FCK  
Date Received07/02/1990
Decision Date 01/16/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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