The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Simmons Shell.
Device ID | K855105 |
510k Number | K855105 |
Device Name: | SIMMONS SHELL |
Classification | Shell, Scleral |
Applicant | MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
Contact | Mark W Furlong |
Correspondent | Mark W Furlong MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
Product Code | HQT |
CFR Regulation Number | 886.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-23 |
Decision Date | 1986-03-31 |