D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM

Unit, Cryophthalmic, Ac-powered

DUTCH OPHTHALMIC USA, INC.

The following data is part of a premarket notification filed by Dutch Ophthalmic Usa, Inc. with the FDA for D.o.r.c. Cryostar Cryosurgical System.

Pre-market Notification Details

Device IDK012821
510k NumberK012821
Device Name:D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
ClassificationUnit, Cryophthalmic, Ac-powered
Applicant DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. P.O. BOX 968 Kingston,  NH  03848
ContactMark W Furlong
CorrespondentMark W Furlong
DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. P.O. BOX 968 Kingston,  NH  03848
Product CodeHRN  
CFR Regulation Number886.4170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-23
Decision Date2001-10-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.