INFINITECH ASPIRATING LASER PROBE

Instrument, Vitreous Aspiration And Cutting, Ac-powered

SURGICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for Infinitech Aspirating Laser Probe.

Pre-market Notification Details

Device IDK946135
510k NumberK946135
Device Name:INFINITECH ASPIRATING LASER PROBE
ClassificationInstrument, Vitreous Aspiration And Cutting, Ac-powered
Applicant SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield,  MO  63005
ContactAlan T Beckman
CorrespondentAlan T Beckman
SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield,  MO  63005
Product CodeHQE  
CFR Regulation Number886.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-16
Decision Date1995-04-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10380657525567 K946135 000
10380657525550 K946135 000
10380657525543 K946135 000

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