The following data is part of a premarket notification filed by Ellex Medical Pty. Ltd. with the FDA for Laserex Lp1532 Photocoagulator.
Device ID | K972514 |
510k Number | K972514 |
Device Name: | LASEREX LP1532 PHOTOCOAGULATOR |
Classification | Laser, Ophthalmic |
Applicant | Ellex Medical Pty. Ltd. 258 HALIFAX ST. Adelaide, S.a., AU 5000 |
Contact | Keith R Degenhardt |
Correspondent | Keith R Degenhardt Ellex Medical Pty. Ltd. 258 HALIFAX ST. Adelaide, S.a., AU 5000 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-07 |
Decision Date | 1997-10-03 |
Summary: | summary |