The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Hs Fiber.
Device ID | K190817 |
510k Number | K190817 |
Device Name: | HS Fiber |
Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
Applicant | Riverpoint Medical 825 NE 25th Ave. Portland, OR 97232 |
Contact | Edwin Anderson |
Correspondent | Edwin Anderson Riverpoint Medical 825 NE 25th Ave. Portland, OR 97232 |
Product Code | GAT |
CFR Regulation Number | 878.5000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-01 |
Decision Date | 2019-05-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M68520189S0 | K190817 | 000 |
M685201890 | K190817 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HS FIBER 85392505 4125447 Live/Registered |
RIVERPOINT MEDICAL, LLC 2011-08-08 |