The following data is part of a premarket notification filed by Sterile Design, Inc. with the FDA for Sterile Design.
| Device ID | K934688 |
| 510k Number | K934688 |
| Device Name: | STERILE DESIGN |
| Classification | General Surgery Tray |
| Applicant | STERILE DESIGN, INC. P.O. BOX 12100 Oldsmar, FL 34677 -0137 |
| Contact | Joyce Moody |
| Correspondent | Joyce Moody STERILE DESIGN, INC. P.O. BOX 12100 Oldsmar, FL 34677 -0137 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-30 |
| Decision Date | 1994-03-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STERILE DESIGN 76553163 not registered Dead/Abandoned |
Maxxim Medical, Inc. 2003-10-01 |
![]() STERILE DESIGN 74119352 1687737 Dead/Cancelled |
JOHNSON & JOHNSON 1990-11-30 |