The following data is part of a premarket notification filed by Dutch Ophthalmic Usa, Inc. with the FDA for D.o.r.c. Microdiathermy System.
Device ID | K962135 |
510k Number | K962135 |
Device Name: | D.O.R.C. MICRODIATHERMY SYSTEM |
Classification | Unit, Cautery, Thermal, Ac-powered |
Applicant | DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. P.O. BOX 968 Kingston, NH 03848 |
Contact | Mark W Furlong |
Correspondent | Mark W Furlong DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. P.O. BOX 968 Kingston, NH 03848 |
Product Code | HQO |
CFR Regulation Number | 886.4115 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-03 |
Decision Date | 1996-08-29 |