REALHAND HIGH DEXTERITY INSTRUMENTS

Laparoscope, General & Plastic Surgery

NOVARE SURGICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Novare Surgical Systems, Inc. with the FDA for Realhand High Dexterity Instruments.

Pre-market Notification Details

Device IDK072715
510k NumberK072715
Device Name:REALHAND HIGH DEXTERITY INSTRUMENTS
ClassificationLaparoscope, General & Plastic Surgery
Applicant NOVARE SURGICAL SYSTEMS, INC. 1070 CONCORD AVE., SUITE 230 Concord,  CA  94520
ContactDavid W Schlerf
CorrespondentDavid W Schlerf
NOVARE SURGICAL SYSTEMS, INC. 1070 CONCORD AVE., SUITE 230 Concord,  CA  94520
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-25
Decision Date2007-10-16
Summary:summary

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