The following data is part of a premarket notification filed by Sharps Compliance, Inc. with the FDA for Sharps Transport Tube, Model 50035.
| Device ID | K073577 |
| 510k Number | K073577 |
| Device Name: | SHARPS TRANSPORT TUBE, MODEL 50035 |
| Classification | Container, Sharps |
| Applicant | SHARPS COMPLIANCE, INC. 614 HUNTERS LANE Brentwood, TN 37027 |
| Contact | David Olmstead |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-12-20 |
| Decision Date | 2008-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634188000899 | K073577 | 000 |