HS SutureTape

Suture, Nonabsorbable, Synthetic, Polyethylene

RIVERPOINT MEDICAL

The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Hs Suturetape.

Pre-market Notification Details

Device IDK153307
510k NumberK153307
Device Name:HS SutureTape
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant RIVERPOINT MEDICAL 825 NE 25th Avenue Portland,  OR  97232
ContactEdwin Anderson
CorrespondentEdwin Anderson
RIVERPOINT MEDICAL 825 NE 25th Avenue Portland,  OR  97232
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-16
Decision Date2016-02-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M68520174S0 K153307 000
M685201740 K153307 000
M68520042S0 K153307 000
M685200421 K153307 000

Trademark Results [HS SutureTape]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HS SUTURETAPE
HS SUTURETAPE
86357890 4715374 Live/Registered
RIVERPOINT MEDICAL, LLC
2014-08-05

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