DENLASER 800 PLUS

Powered Laser Surgical Instrument

CAO GROUP, INC.

The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Denlaser 800 Plus.

Pre-market Notification Details

Device IDK062619
510k NumberK062619
Device Name:DENLASER 800 PLUS
ClassificationPowered Laser Surgical Instrument
Applicant CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan,  UT  84084
ContactRobert K Larsen
CorrespondentRobert K Larsen
CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan,  UT  84084
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-05
Decision Date2006-11-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00872320003494 K062619 000
00872320001391 K062619 000
00872320001438 K062619 000
00872320001872 K062619 000
00872320002534 K062619 000
00872320002541 K062619 000
00872320002633 K062619 000
00872320003173 K062619 000
00872320003265 K062619 000
00872320003388 K062619 000
00872320003395 K062619 000
00872320003432 K062619 000
00872320003449 K062619 000
00872320003487 K062619 000
00872320001360 K062619 000

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