The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Ceeon Easysert Intraocular Lens Injector, Model Imp-1.
Device ID | K002556 |
510k Number | K002556 |
Device Name: | CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 |
Classification | Folders And Injectors, Intraocular Lens (iol) |
Applicant | PHARMACIA & UPJOHN CO. 592 CERESIA COURT Pickerington,, OH 43147 |
Contact | Toni D Elliott |
Correspondent | Toni D Elliott PHARMACIA & UPJOHN CO. 592 CERESIA COURT Pickerington,, OH 43147 |
Product Code | MSS |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-17 |
Decision Date | 2000-10-31 |