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Oculo Plastik, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
2
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K112176SILICONE SPHERESSeptember 15, 2011
K073293DURETTE IMPLANTMarch 19, 2008
K040689EYE SPHERE IMPLANTSJune 10, 2004
K934834EPTFE SHEET COVERING FOR OCULAR IMPLANTMay 5, 1994
K915630OPHTIMPLANTMarch 2, 1992
K901002O'DONNELL, SOCKET RECONSTRUCTION PROSTHESESMay 22, 1990
K900929PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERALMay 18, 1990
K900930SPIVEY-ALLEN ORBITAL FLOOR IMPLANTMay 15, 1990
K900928COX MALAR EMINENCE IMPLANTSMay 15, 1990
K900927CODERE-DURETTE ORBITAL FLOOR IMPLANTMay 15, 1990
K900081NEW ALLEN IMPLANTMarch 23, 1990
K900080NEW IOWA MOTILITY IMPLANTMarch 23, 1990