LIHTAN 532 LASER

Powered Laser Surgical Instrument

BUCKMAN CO., INC.

The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Lihtan 532 Laser.

Pre-market Notification Details

Device IDK951117
510k NumberK951117
Device Name:LIHTAN 532 LASER
ClassificationPowered Laser Surgical Instrument
Applicant BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord,  CA  94520
ContactDavid W Schlerf
CorrespondentDavid W Schlerf
BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord,  CA  94520
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-10
Decision Date1995-10-18

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