HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED

Suture, Nonabsorbable, Synthetic, Polyethylene

RIVERPOINT MEDICAL

The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Hs Fiber (polyblend), River Bond, Riversilk (silk), Riverpro (polypropylene), Riverlon (nylon) Model Veries By Size/need.

Pre-market Notification Details

Device IDK100006
510k NumberK100006
Device Name:HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant RIVERPOINT MEDICAL 825 NE 25TH AVE. Portland,  OR  97232
ContactDoug Rowley
CorrespondentDoug Rowley
RIVERPOINT MEDICAL 825 NE 25TH AVE. Portland,  OR  97232
Product CodeGAT  
Subsequent Product CodeGAP
Subsequent Product CodeGAR
Subsequent Product CodeGAS
Subsequent Product CodeGAW
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-04
Decision Date2010-05-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20653405002083 K100006 000
M68520053S0 K100006 000
M685200531 K100006 000
M685200501 K100006 000
M68520049S0 K100006 000
M685200491 K100006 000
M68520035S0 K100006 000
M685200351 K100006 000
M68520034S0 K100006 000
M68520032S0 K100006 000
20653405005480 K100006 000
M685200541 K100006 000
M68520054S0 K100006 000
M685200551 K100006 000
20653405002052 K100006 000
20653405002045 K100006 000
M68520188S0 K100006 000
M685201880 K100006 000
M685200601 K100006 000
M68520059S0 K100006 000
M685200591 K100006 000
M68520056S0 K100006 000
M685200561 K100006 000
M68520055S0 K100006 000
20653405005473 K100006 000

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