The following data is part of a premarket notification filed by Alcon, Inc. with the FDA for Inteliport Occluding Device.
Device ID | K040231 |
510k Number | K040231 |
Device Name: | INTELIPORT OCCLUDING DEVICE |
Classification | Plug, Punctum |
Applicant | ALCON, INC. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
Contact | Kim B Kracke |
Correspondent | Kim B Kracke ALCON, INC. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
Product Code | LZU |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-02-02 |
Decision Date | 2004-07-13 |
Summary: | summary |