The following data is part of a premarket notification filed by Dutch Ophthalmic Usa, Inc. with the FDA for D.o.r.c. Hexon Illumination System.
Device ID | K973229 |
510k Number | K973229 |
Device Name: | D.O.R.C. HEXON ILLUMINATION SYSTEM |
Classification | Endoilluminator |
Applicant | DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. Kingston, NH 03848 |
Contact | Mark W Furlong |
Correspondent | Mark W Furlong DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. Kingston, NH 03848 |
Product Code | MPA |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-27 |
Decision Date | 1997-11-25 |
Summary: | summary |