The following data is part of a premarket notification filed by Oasis Medical, Inc. with the FDA for Collagen Intracanalicular Plug.
Device ID | K946357 |
510k Number | K946357 |
Device Name: | COLLAGEN INTRACANALICULAR PLUG |
Classification | Plug, Punctum |
Applicant | OASIS MEDICAL, INC. 514 SOUTH VERMONT AVE. P.O. BOX 1137 Glendora, CA 91741 |
Contact | James Christensen |
Correspondent | James Christensen OASIS MEDICAL, INC. 514 SOUTH VERMONT AVE. P.O. BOX 1137 Glendora, CA 91741 |
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 | 1994-12-30 |
Decision Date | 1995-02-07 |