The following data is part of a premarket notification filed by Lacrimedics, Inc. with the FDA for Herrick Ultimate Punctum Plug.
Device ID | K963501 |
510k Number | K963501 |
Device Name: | HERRICK ULTIMATE PUNCTUM PLUG |
Classification | Plug, Punctum |
Applicant | LACRIMEDICS, INC. 190 NORTH ARROWHEAD AVE., SUITE B Rialto, CA 92376 |
Contact | Robert S Herrick |
Correspondent | Robert S Herrick LACRIMEDICS, INC. 190 NORTH ARROWHEAD AVE., SUITE B Rialto, CA 92376 |
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 | 1996-09-03 |
Decision Date | 1997-04-14 |
Summary: | summary |