PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT

Suture, Surgical, Absorbable, Polydioxanone

RIVERPOINT MEDICAL

The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Pdm, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut.

Pre-market Notification Details

Device IDK100461
510k NumberK100461
Device Name:PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant RIVERPOINT MEDICAL 825 NE 25TH AVE. Portland,  OR  97232
ContactDoug Rowley
CorrespondentDoug Rowley
RIVERPOINT MEDICAL 825 NE 25TH AVE. Portland,  OR  97232
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-18
Decision Date2010-07-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10812444021162 K100461 000
00812444021004 K100461 000
00812444020991 K100461 000
00812444020984 K100461 000
00812444020977 K100461 000
00812444020960 K100461 000
00812444020953 K100461 000
00812444020946 K100461 000
00812444020939 K100461 000
00812444020922 K100461 000
00812444020915 K100461 000
00812444020908 K100461 000
00812444021011 K100461 000
00812444021035 K100461 000
00812444021042 K100461 000
10812444021155 K100461 000
10812444021148 K100461 000
00812444021134 K100461 000
10812444021124 K100461 000
00812444021110 K100461 000
00812444021103 K100461 000
00812444021097 K100461 000
00812444021080 K100461 000
00812444021073 K100461 000
00812444021066 K100461 000
00812444021059 K100461 000
00812444020892 K100461 000
00812444020885 K100461 000
00812444020175 K100461 000
10810020085782 K100461 000
10810020085775 K100461 000
10810020085768 K100461 000
10810020085010 K100461 000
10810020084990 K100461 000
10810020084921 K100461 000
10810020084808 K100461 000
10810020084792 K100461 000
10810020084723 K100461 000
10810020084716 K100461 000
10810020084709 K100461 000
10812444021025 K100461 000
10812444029298 K100461 000
10810020084075 K100461 000
00812444020151 K100461 000
00812444020144 K100461 000
00812444020137 K100461 000
00812444020120 K100461 000
10810020081999 K100461 000
10810020081982 K100461 000
10810020081968 K100461 000
10810020082217 K100461 000
10810020082002 K100461 000
10810020085294 K100461 000
10810020084082 K100461 000
10810020084693 K100461 000
10812444028109 K100461 000
10812444024262 K100461 000
10812444024255 K100461 000
10812444024248 K100461 000
10812444024224 K100461 000
10812444024217 K100461 000
10812444024200 K100461 000
10812444024187 K100461 000
10812444024170 K100461 000
10812444024101 K100461 000
10812444024095 K100461 000
10812444024088 K100461 000
10812444024507 K100461 000
00812444024517 K100461 000
10812444024644 K100461 000
10812444028093 K100461 000
10812444027393 K100461 000
10812444026440 K100461 000
10812444025870 K100461 000
00812444025798 K100461 000
10812444024705 K100461 000
10812444024699 K100461 000
10812444024682 K100461 000
10812444024675 K100461 000
10812444024668 K100461 000
00812444024654 K100461 000
10812444024071 K100461 000
10812444024064 K100461 000
10812444024057 K100461 000
10812444021285 K100461 000
10812444021278 K100461 000
10812444021261 K100461 000
10812444021254 K100461 000
10812444021247 K100461 000
10812444021230 K100461 000
10812444021223 K100461 000
10812444021216 K100461 000
10812444021209 K100461 000
10812444021193 K100461 000
10812444021186 K100461 000
10812444021292 K100461 000
10812444021308 K100461 000
10812444021315 K100461 000
10812444024040 K100461 000
10812444024033 K100461 000
10812444024026 K100461 000
10812444024019 K100461 000
10812444024002 K100461 000
10812444023999 K100461 000
10812444023982 K100461 000
10812444023395 K100461 000
00812444023169 K100461 000
10812444021339 K100461 000
10812444021322 K100461 000
10812444021179 K100461 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.