The following data is part of a premarket notification filed by Ttl Medical with the FDA for Uni-site.
Device ID | K953018 |
510k Number | K953018 |
Device Name: | UNI-SITE |
Classification | Dressing, Wound And Burn, Occlusive |
Applicant | TTL MEDICAL 10537 LEXINGTON DR. KNOXVILLE, TN 37932 |
Contact | H. CLAY WILSON |
Correspondent | H. CLAY WILSON TTL MEDICAL 10537 LEXINGTON DR. KNOXVILLE, TN 37932 |
Product Code | MGP |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-29 |
Decision Date | 1995-09-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() UNI-SITE 74291189 not registered Dead/Abandoned |
EDWARDS OPTICAL CORPORATION 1992-07-06 |