HS Fiber

Suture, Nonabsorbable, Synthetic, Polyethylene

Riverpoint Medical, LLC

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

Pre-market Notification Details

Device IDK202242
510k NumberK202242
Device Name:HS Fiber
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant Riverpoint Medical, LLC 825 NE 25th Ave Portland,  OR  97232
ContactEdwin Anderson
CorrespondentEdwin Anderson
Riverpoint Medical, LLC 825 NE 25th Ave Portland,  OR  97232
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-10
Decision Date2020-09-10

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