510(k) K844895

OMS SILICONE OIL INJECTOR by Optical Micro Systems, Inc. — Product Code LWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1985
Date Received
December 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluid, Intraocular
Device Class
Class III
Regulation Number
886.4275
Review Panel
OP
Submission Type