meddevicedb.com FDA Device Reference

FDA Product Code

FDA Product Code EPP — Clearance Directory

Device Class
Class I
Assigned Panel
Ear, Nose, Throat
21 CFR Citation
874.5800

510(k) Clearances — 15 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K942158 AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS Wfr/Aquaplast Corp. 1994-07-29 Traditional PDF ↗
K942724 EXTERNAL NASAL SPLINT Micromed Development Corp. 1994-07-08 Traditional PDF ↗
K895502 MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT Microbio-Medics, Inc. 1989-12-08 Traditional PDF ↗
K890599 HOOD NASAL SPLINT Hood Laboratories 1989-03-17 Traditional PDF ↗
K882244 RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT Richards Medical Co., Inc. 1988-06-23 Traditional PDF ↗
K872905 AMERICAN NASAL SPONGE American Silk Sutures, Inc. 1987-09-04 Traditional PDF ↗
K864932 'EXMOOR' CAWOOD NASAL SPLINTS Exmoor Plastics , Ltd. 1987-03-04 Traditional PDF ↗
K864930 'EXMOOR' ATKINS NASAL SPLINT Exmoor Plastics , Ltd. 1987-03-04 Traditional PDF ↗
K864933 'EXMOOR' SHAH & MACKAY NASAL SPLINTS Exmoor Plastics , Ltd. 1987-03-04 Traditional PDF ↗
K864934 'EXMOOR' SHAH SILICONE DISCS Exmoor Plastics , Ltd. 1987-01-28 Traditional PDF ↗
K863382 CANNON NASAL SPLINT Treace Medical, Inc. 1986-10-07 Traditional PDF ↗
K862496 MICROTEK INTRANASAL SPLINT Microtek Medical, Inc. 1986-07-14 Traditional PDF ↗
K810738 GOODE MAGNETIC NASAL SPLINT Xomed, Inc. 1981-03-31 Traditional PDF ↗
K791681 THE DENVER SPLINT Xomed, Inc. 1979-10-22 Traditional PDF ↗
K791053 THE DENVER SPLINT Ronald D. Shippert, M.D. 1979-08-16 Traditional PDF ↗

Product code EPP · Class I · Ear, Nose, Throat. Data: openFDA.