510(k) K002556

CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 by Pharmacia & Upjohn Co. — Product Code MSS

K002556 is an FDA 510(k) premarket notification submitted by Pharmacia & Upjohn Co. for the device "CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1". The FDA issued a decision of Substantially Equivalent on October 31, 2000. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Pharmacia & Upjohn Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2000
Date Received
August 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Folders And Injectors, Intraocular Lens (Iol)
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type