The following data is part of a premarket notification filed by Moist Medical Inc. with the FDA for Moist Punctal Plug System.
Device ID | K021936 |
510k Number | K021936 |
Device Name: | MOIST PUNCTAL PLUG SYSTEM |
Classification | Plug, Punctum |
Applicant | MOIST MEDICAL INC. 2180 WICKERSHAM LN. Germantown, TN 38139 |
Contact | George W Murray |
Correspondent | George W Murray MOIST MEDICAL INC. 2180 WICKERSHAM LN. Germantown, TN 38139 |
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 | 2002-06-12 |
Decision Date | 2002-10-16 |
Summary: | summary |