The following data is part of a premarket notification filed by Biodex Medical Systems, Inc. with the FDA for Sharps Container, Model 039-413.
| Device ID | K063666 |
| 510k Number | K063666 |
| Device Name: | SHARPS CONTAINER, MODEL 039-413 |
| Classification | Container, Sharps |
| Applicant | BIODEX MEDICAL SYSTEMS, INC. 20 RAMSAY RD. Shirley, NY 11967 |
| Contact | Clyde Schlein |
| Correspondent | Clyde Schlein BIODEX MEDICAL SYSTEMS, INC. 20 RAMSAY RD. Shirley, NY 11967 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-11 |
| Decision Date | 2007-01-25 |
| Summary: | summary |