The following data is part of a premarket notification filed by Optimedica Corporation with the FDA for Pascal Streamline Photocoagulator.
Device ID | K100019 |
510k Number | K100019 |
Device Name: | PASCAL STREAMLINE PHOTOCOAGULATOR |
Classification | Laser, Ophthalmic |
Applicant | OPTIMEDICA CORPORATION 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
Contact | Darlene Crockett-billing |
Correspondent | Darlene Crockett-billing OPTIMEDICA CORPORATION 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-01-05 |
Decision Date | 2010-05-04 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PASCAL STREAMLINE PHOTOCOAGULATOR 77708955 not registered Dead/Abandoned |
OptiMedica Corporation 2009-04-07 |