The following data is part of a premarket notification filed by Odyssey Medical, Inc. with the FDA for Punctual Occluder.
| Device ID | K970631 |
| 510k Number | K970631 |
| Device Name: | PUNCTUAL OCCLUDER |
| Classification | Plug, Punctum |
| Applicant | ODYSSEY MEDICAL, INC. 1710 SHELBY OAKS DR., SUITE 21 Memphis, TN 38134 |
| Contact | Raymond G Wallace |
| Correspondent | Raymond G Wallace ODYSSEY MEDICAL, INC. 1710 SHELBY OAKS DR., SUITE 21 Memphis, TN 38134 |
| 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 | 1997-02-19 |
| Decision Date | 1997-04-23 |
| Summary: | summary |