HydroCision SpineJet System

Arthroscope

HydroCision, Inc.

The following data is part of a premarket notification filed by Hydrocision, Inc. with the FDA for Hydrocision Spinejet System.

Pre-market Notification Details

Device IDK200729
510k NumberK200729
Device Name:HydroCision SpineJet System
ClassificationArthroscope
Applicant HydroCision, Inc. 267 Boston Rd, Suite 28 North Billerica,  MA  01862
ContactMark J Lewis
CorrespondentYashesh Rawal
MAE Consulting Group, LLC 119 North Road Deerfield,  NH  03037
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-20
Decision Date2020-04-16

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