The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Vilet Vilet Quick.
Device ID | K120556 |
510k Number | K120556 |
Device Name: | VILET VILET QUICK |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | RIVERPOINT MEDICAL 825 NE 25th Ave Portland, OR 97232 |
Contact | Doug Rowley |
Correspondent | Doug Rowley RIVERPOINT MEDICAL 825 NE 25th Ave Portland, OR 97232 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-24 |
Decision Date | 2012-05-23 |
Summary: | summary |