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 |