The following data is part of a premarket notification filed by Vitrolife Gmbh with the FDA for Lasershot M, Navilase.
Device ID | K192008 |
510k Number | K192008 |
Device Name: | LaserShot M, NaviLase |
Classification | System, Assisted Reproduction Laser |
Applicant | Vitrolife GmbH Dr. -Pauling-Str.9 Bruckberg, DE 84079 |
Contact | Susanne Schweitzer |
Correspondent | Susanne Schweitzer Vitrolife GmbH Dr. -Pauling-Str.9 Bruckberg, DE 84079 |
Product Code | MRX |
CFR Regulation Number | 884.6200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-07-29 |
Decision Date | 2020-03-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260604170028 | K192008 | 000 |
04260604170011 | K192008 | 000 |