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FDA Product Code

FDA Product Code IWP — Clearance Directory

Device Class
Class I
Assigned Panel
Radiology
21 CFR Citation
892.6500

510(k) Clearances — 5 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K920538 PROTECTIVE RADIOGRAFIC GLOVE Burkhart Roentgen Intl., Inc. 1992-05-29 Traditional PDF ↗
K904878 SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. Hpi, Inc. 1991-03-07 Traditional PDF ↗
K905086 HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES Hpi, Inc. 1990-12-03 Traditional PDF ↗
K900972 RADIATION PROTECTION GLOVES Infab Corp. 1990-05-01 Traditional PDF ↗
K844683 IMAGEN CHLAMYDIA TEST Boots-Celltech Diagnostics, Inc. 1985-02-06 Traditional PDF ↗

Product code IWP · Class I · Radiology. Data: openFDA.