The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Ocu-guard And Ocu-guard Supple.
Device ID | K983581 |
510k Number | K983581 |
Device Name: | OCU-GUARD AND OCU-GUARD SUPPLE |
Classification | Implant, Orbital, Extra-ocular |
Applicant | BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
Contact | Dianna L Geck |
Correspondent | Dianna L Geck BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
Product Code | HQX |
CFR Regulation Number | 886.3340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-13 |
Decision Date | 1998-11-06 |
Summary: | summary |