The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Dc-3300 Laser Diode Photocoagulator.
Device ID | K013760 |
510k Number | K013760 |
Device Name: | DC-3300 LASER DIODE PHOTOCOAGULATOR |
Classification | Laser, Ophthalmic |
Applicant | NIDEK, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
Contact | Carol Patterson |
Correspondent | Carol Patterson NIDEK, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-11-13 |
Decision Date | 2002-02-11 |
Summary: | summary |