510(k) K912105

EYE TRAY by Medical Device Inspection Co., Inc. — Product Code LRP

K912105 is an FDA 510(k) premarket notification submitted by Medical Device Inspection Co., Inc. for the device "EYE TRAY". The FDA issued a decision of Substantially Equivalent on August 29, 1991. The device falls under product code LRP (Tray, Surgical), a Class I device regulated under 21 CFR 878.4800. Medical Device Inspection Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1991
Date Received
May 13, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type