FLEXLINE CLAMP

Clamp, Vascular

NOVARE SURGICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Novare Surgical Systems, Inc. with the FDA for Flexline Clamp.

Pre-market Notification Details

Device IDK010727
510k NumberK010727
Device Name:FLEXLINE CLAMP
ClassificationClamp, Vascular
Applicant NOVARE SURGICAL SYSTEMS, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill,  CA  94523 -3389
ContactDavid W Schlerf
CorrespondentDavid W Schlerf
NOVARE SURGICAL SYSTEMS, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill,  CA  94523 -3389
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-12
Decision Date2002-08-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857987006248 K010727 000
00850001784955 K010727 000
00850001784962 K010727 000
00852621004215 K010727 000
00852621004222 K010727 000
00852621004239 K010727 000
00852621004246 K010727 000
00852621004253 K010727 000
00852621004260 K010727 000
00852621004277 K010727 000
00852621004284 K010727 000
00852621004291 K010727 000
00852621004307 K010727 000
00857987006200 K010727 000
00857987006217 K010727 000
00857987006224 K010727 000
00857987006231 K010727 000
00850001784948 K010727 000

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