The following data is part of a premarket notification filed by Contamac Ltd. with the FDA for Nutrifill.
Device ID | K181566 |
510k Number | K181566 |
Device Name: | Nutrifill |
Classification | Products, Contact Lens Care, Rigid Gas Permeable |
Applicant | Contamac Ltd. Carlton House Shire Hill Saffron Walden, GB Cb11 3au |
Contact | Rob Mcgregor |
Correspondent | Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068 |
Product Code | MRC |
CFR Regulation Number | 886.5918 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-14 |
Decision Date | 2018-10-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850012123002 | K181566 | 000 |
00850012123019 | K181566 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NUTRIFILL 87852056 not registered Live/Pending |
Contamac Ltd. 2018-03-27 |