The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Clearcut S Safety Knife.
Device ID | K110166 |
510k Number | K110166 |
Device Name: | CLEARCUT S SAFETY KNIFE |
Classification | Knife, Ophthalmic |
Applicant | ALCON RESEARCH, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
Contact | Tonya Morgan |
Correspondent | Tonya Morgan ALCON RESEARCH, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
Product Code | HNN |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-20 |
Decision Date | 2011-05-20 |
Summary: | summary |