AUTOMATED CORNEAL TREPHINE

Engine, Trephine, Accessories, Ac-powered

LASER CENTER DEV. CORP.

The following data is part of a premarket notification filed by Laser Center Dev. Corp. with the FDA for Automated Corneal Trephine.

Pre-market Notification Details

Device IDK981063
510k NumberK981063
Device Name:AUTOMATED CORNEAL TREPHINE
ClassificationEngine, Trephine, Accessories, Ac-powered
Applicant LASER CENTER DEV. CORP. 1028 S. KIRKWOOD RD. SUITE A St. Louis,  MO  63122 -7222
ContactFrancis E O'donnell, Jr.
CorrespondentFrancis E O'donnell, Jr.
LASER CENTER DEV. CORP. 1028 S. KIRKWOOD RD. SUITE A St. Louis,  MO  63122 -7222
Product CodeHRG  
CFR Regulation Number886.4070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-23
Decision Date1998-06-23
Summary:summary

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