The following data is part of a premarket notification filed by Bostonsight with the FDA for Bostonsight Pd Prosthetic Device.
Device ID | K161461 |
510k Number | K161461 |
Device Name: | BostonSight PD Prosthetic Device |
Classification | Lens, Contact (other Material) - Daily |
Applicant | BostonSight 464 Hillside Avenue, Suite 205 Needham, MA 02494 |
Contact | Gene Guselli |
Correspondent | Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068 |
Product Code | HQD |
CFR Regulation Number | 886.5916 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-05-26 |
Decision Date | 2016-07-25 |
Summary: | summary |