INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER

Laser, Ophthalmic

INFINITECH, INC.

The following data is part of a premarket notification filed by Infinitech, Inc. with the FDA for Infinitech Multi-spot Slit Lamp Laser Adapter.

Pre-market Notification Details

Device IDK971950
510k NumberK971950
Device Name:INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER
ClassificationLaser, Ophthalmic
Applicant INFINITECH, INC. 750 GODDARD AVE. Chesterfield,  MO  63005
ContactAlan T Beckman
CorrespondentAlan T Beckman
INFINITECH, INC. 750 GODDARD AVE. Chesterfield,  MO  63005
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-28
Decision Date1997-08-01
Summary:summary

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