The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Pdo Absorbable Punctum Plug.
Device ID | K150288 |
510k Number | K150288 |
Device Name: | PDO Absorbable Punctum Plug |
Classification | Plug, Punctum |
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 | LZU |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-05 |
Decision Date | 2015-08-28 |
Summary: | summary |