The following data is part of a premarket notification filed by Duckworth & Kent, Ltd. with the FDA for Duckworth & Kent Ltd Lens Delivery System, Model Dk7788.
Device ID | K060995 |
510k Number | K060995 |
Device Name: | DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 |
Classification | Folders And Injectors, Intraocular Lens (iol) |
Applicant | DUCKWORTH & KENT, LTD. 7 MARQUIS BUSINESS CENTRE ROYSTON RD. Baldock, Hertfordshire, GB Sg7 6xl |
Contact | Martin Lock |
Correspondent | Martin Lock DUCKWORTH & KENT, LTD. 7 MARQUIS BUSINESS CENTRE ROYSTON RD. Baldock, Hertfordshire, GB Sg7 6xl |
Product Code | MSS |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-11 |
Decision Date | 2006-05-22 |