The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Hs Suturetape.
Device ID | K153307 |
510k Number | K153307 |
Device Name: | HS SutureTape |
Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
Applicant | RIVERPOINT MEDICAL 825 NE 25th Avenue Portland, OR 97232 |
Contact | Edwin Anderson |
Correspondent | Edwin Anderson RIVERPOINT MEDICAL 825 NE 25th Avenue 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 | 2015-11-16 |
Decision Date | 2016-02-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M68520174S0 | K153307 | 000 |
M685201740 | K153307 | 000 |
M68520042S0 | K153307 | 000 |
M685200421 | K153307 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HS SUTURETAPE 86357890 4715374 Live/Registered |
RIVERPOINT MEDICAL, LLC 2014-08-05 |