The following data is part of a premarket notification filed by Allergan, Inc with the FDA for Refresh Relieva For Contacts.
Device ID | K190674 |
510k Number | K190674 |
Device Name: | REFRESH RELIEVA For CONTACTS |
Classification | Accessories, Soft Lens Products |
Applicant | Allergan, Inc 2525 Dupont Drive Irvine, CA 92623 -9534 |
Contact | Emily Huang |
Correspondent | Emily Huang Allergan, Inc 2525 Dupont Drive Irvine, CA 92623 -9534 |
Product Code | LPN |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-15 |
Decision Date | 2019-08-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00300236632083 | K190674 | 000 |