KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS

Couch, Radiation Therapy, Powered

WFR/AQUAPLAST CORP.

The following data is part of a premarket notification filed by Wfr/aquaplast Corp. with the FDA for Kvue Igrt Treatment Table Top, Rt-4551kv, Kvue Inserts And Accessories, Various.

Pre-market Notification Details

Device IDK060671
510k NumberK060671
Device Name:KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS
ClassificationCouch, Radiation Therapy, Powered
Applicant WFR/AQUAPLAST CORP. 30 LAWLINS PARK Wyckoff,  NJ  07481
ContactJ. Damon Kirk
CorrespondentJ. Damon Kirk
WFR/AQUAPLAST CORP. 30 LAWLINS PARK Wyckoff,  NJ  07481
Product CodeJAI  
CFR Regulation Number892.5770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-14
Decision Date2006-05-04

NIH GUDID Devices

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