The following data is part of a premarket notification filed by Sharps Compliance, Inc. with the FDA for Sharps Compliance Container.
| Device ID | K083129 |
| 510k Number | K083129 |
| Device Name: | SHARPS COMPLIANCE CONTAINER |
| Classification | Container, Sharps |
| Applicant | SHARPS COMPLIANCE, INC. 9220 KIRBY DR., SUITE 500 Houston, TX 77054 |
| Contact | Al Aladwani |
| Correspondent | Al Aladwani SHARPS COMPLIANCE, INC. 9220 KIRBY DR., SUITE 500 Houston, TX 77054 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-22 |
| Decision Date | 2008-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634188000950 | K083129 | 000 |
| 00634188002022 | K083129 | 000 |
| 00634188001742 | K083129 | 000 |
| 00634188001858 | K083129 | 000 |
| 00634188001865 | K083129 | 000 |
| 00634188001896 | K083129 | 000 |
| 00634188001919 | K083129 | 000 |
| 00634188001926 | K083129 | 000 |
| 00634188000912 | K083129 | 000 |
| 00634188000943 | K083129 | 000 |
| 00634188002046 | K083129 | 000 |