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 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 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 86357890 4715374 Live/Registered |
RIVERPOINT MEDICAL, LLC 2014-08-05 |
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