The following data is part of a premarket notification filed by Trillium Medical, Inc. with the FDA for Micropulse Phacoemulsification System.
Device ID | K051186 |
510k Number | K051186 |
Device Name: | MICROPULSE PHACOEMULSIFICATION SYSTEM |
Classification | Unit, Phacofragmentation |
Applicant | TRILLIUM MEDICAL, INC. P.O. BOX 2601 Poulsbo, WA 98370 |
Contact | Michael H Curtis |
Correspondent | Michael H Curtis TRILLIUM MEDICAL, INC. P.O. BOX 2601 Poulsbo, WA 98370 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-09 |
Decision Date | 2005-08-18 |
Summary: | summary |