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 |