The following data is part of a premarket notification filed by Winfield Industries with the FDA for Sharps-tainer.
| Device ID | K961878 |
| 510k Number | K961878 |
| Device Name: | SHARPS-TAINER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | WINFIELD INDUSTRIES 7106 CROSSROADS BLVD., SUITE 201 Brentwood, TN 37027 |
| Contact | David Olmstead |
| Correspondent | David Olmstead WINFIELD INDUSTRIES 7106 CROSSROADS BLVD., SUITE 201 Brentwood, TN 37027 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-15 |
| Decision Date | 1996-06-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SHARPS-TAINER 86795593 4913830 Live/Registered |
Inteplast Group Ltd. 2015-10-22 |
![]() SHARPS-TAINER 73423318 1324568 Dead/Cancelled |
Winfield Industries 1983-04-27 |