The following data is part of a premarket notification filed by Odyssey Medical, Inc. with the FDA for Flow Controller.
| Device ID | K090938 |
| 510k Number | K090938 |
| Device Name: | FLOW CONTROLLER |
| Classification | Plug, Punctum |
| Applicant | ODYSSEY MEDICAL, INC. 2975 BROTHER BLVD Bartlett, TN 38133 |
| Contact | Terry R Green |
| Correspondent | Terry R Green ODYSSEY MEDICAL, INC. 2975 BROTHER BLVD Bartlett, TN 38133 |
| 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 | 2009-04-03 |
| Decision Date | 2009-06-04 |
| Summary: | summary |