The following data is part of a premarket notification filed by Daniels Corporation Pty, Inc. with the FDA for Sharpsmart Disposable Sharps Container, Model S2.
Device ID | K091736 |
510k Number | K091736 |
Device Name: | SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2 |
Classification | Container, Sharps |
Applicant | DANIELS CORPORATION PTY, INC. 2133-126 UPTON DRIVE SUITE 436 Virginia Beach, VA 23454 |
Contact | Andrea Arredondo |
Correspondent | Andrea Arredondo DANIELS CORPORATION PTY, INC. 2133-126 UPTON DRIVE SUITE 436 Virginia Beach, VA 23454 |
Product Code | MMK |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-11 |
Decision Date | 2009-10-30 |
Summary: | summary |