The following data is part of a premarket notification filed by Delta Life Science, Inc. with the FDA for Delta Punctum Plug.
| Device ID | K050851 |
| 510k Number | K050851 |
| Device Name: | DELTA PUNCTUM PLUG |
| Classification | Plug, Punctum |
| Applicant | DELTA LIFE SCIENCE, INC. 1975 NONCONNAH BLVD. Memphis, TN 38132 |
| Contact | George W Murray |
| Correspondent | George W Murray DELTA LIFE SCIENCE, INC. 1975 NONCONNAH BLVD. Memphis, TN 38132 |
| 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 | 2005-04-04 |
| Decision Date | 2005-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810003223644 | K050851 | 000 |
| 30810003223556 | K050851 | 000 |
| 30810003223563 | K050851 | 000 |
| 30810003223570 | K050851 | 000 |
| 30810003223587 | K050851 | 000 |
| 10810003223590 | K050851 | 000 |
| 10810003223606 | K050851 | 000 |
| 10810003223613 | K050851 | 000 |
| 10810003223620 | K050851 | 000 |
| 10810003223637 | K050851 | 000 |
| 30810003223549 | K050851 | 000 |