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 |