The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Ophthalmic Trichiasis Probe.
Device ID | K923629 |
510k Number | K923629 |
Device Name: | OPHTHALMIC TRICHIASIS PROBE |
Classification | Unit, Cryophthalmic |
Applicant | MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
Contact | Roger O'brien |
Correspondent | Roger O'brien MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
Product Code | HPS |
CFR Regulation Number | 886.4170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-21 |
Decision Date | 1992-10-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10850510007597 | K923629 | 000 |