The following data is part of a premarket notification filed by Acuity Polymers, Inc. with the FDA for Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens.
Device ID | K163254 |
510k Number | K163254 |
Device Name: | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens |
Classification | Lens, Contact (other Material) - Daily |
Applicant | Acuity Polymers, Inc. 1667 Lake Avenue, Suite 354 Rochester, NY 14615 |
Contact | James A Bonafini |
Correspondent | James A Bonafini Acuity Polymers, Inc. 1667 Lake Avenue, Suite 354 Rochester, NY 14615 |
Product Code | HQD |
CFR Regulation Number | 886.5916 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-21 |
Decision Date | 2017-01-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850203008019 | K163254 | 000 |