GOLDLENS(TM)

Electrode, Corneal

DORAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Doran Instruments, Inc. with the FDA for Goldlens(tm).

Pre-market Notification Details

Device IDK913239
510k NumberK913239
Device Name:GOLDLENS(TM)
ClassificationElectrode, Corneal
Applicant DORAN INSTRUMENTS, INC. 410 GREAT RD. P.O. BOX 1070 Littleton,  MA  01460
ContactBruce Doran
CorrespondentBruce Doran
DORAN INSTRUMENTS, INC. 410 GREAT RD. P.O. BOX 1070 Littleton,  MA  01460
Product CodeHLZ  
CFR Regulation Number886.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-22
Decision Date1992-01-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850594007011 K913239 000
00855730007337 K913239 000
00855730007320 K913239 000

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