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FDA Product Code

FDA Product Code FAK — Clearance Directory

Device Class
Class II
21 CFR Citation
876.1500

510(k) Clearances — 2 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K812810 PENTAX FLEXIBLE DRIODENOFIBERSCOPE Pentax Precision Instrument Corp. 1981-11-17 Traditional PDF ↗
K760822 MODEL TX-8 PANENDOSCOPE American Cystocope Makers, Inc. 1976-10-21 Traditional PDF ↗

Product code FAK · Class II · Gastroenterology, Urology. Data: openFDA.