OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM

Powered Laser Surgical Instrument

OMNIGUIDE, INC.

The following data is part of a premarket notification filed by Omniguide, Inc. with the FDA for Omniguide Sterile Waveguide Adapter System.

Pre-market Notification Details

Device IDK073409
510k NumberK073409
Device Name:OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant OMNIGUIDE, INC. ONE KENDALL SQUARE, BLDG 100 3RD FLOOR Cambridge,  MA  02139
ContactDouglas W Woodruff
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-12-04
Decision Date2007-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10894338002693 K073409 000

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