The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Endophotocoagulation Probe.
Device ID | K863591 |
510k Number | K863591 |
Device Name: | ENDOPHOTOCOAGULATION PROBE |
Classification | Laser, Ophthalmic |
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 | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-15 |
Decision Date | 1986-10-10 |