Rhapsody H-30 Holmium Laser System

Powered Laser Surgical Instrument

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Rhapsody H-30 Holmium Laser System.

Pre-market Notification Details

Device IDK172325
510k NumberK172325
Device Name:Rhapsody H-30 Holmium Laser System
ClassificationPowered Laser Surgical Instrument
Applicant Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington,  IN  47402
ContactColin Jacob
CorrespondentColin Jacob
Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington,  IN  47402
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-01
Decision Date2017-10-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00827002476257 K172325 000

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