The following data is part of a premarket notification filed by Biosystems with the FDA for Biobox With Funnel Top (small, Medium, Large, And X-large).
| Device ID | K950898 |
| 510k Number | K950898 |
| Device Name: | BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE) |
| Classification | Container, Sharps |
| Applicant | BIOSYSTEMS 210 SHERWOOD AVE. Farmingdale, NY 11735 |
| Contact | Jane E Rubinstein |
| Correspondent | Jane E Rubinstein BIOSYSTEMS 210 SHERWOOD AVE. Farmingdale, NY 11735 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858775006273 | K950898 | 000 |
| 00858775006105 | K950898 | 000 |
| 00858775006129 | K950898 | 000 |
| 00858775006136 | K950898 | 000 |
| 00858775006143 | K950898 | 000 |
| 00858775006150 | K950898 | 000 |
| 00858775006181 | K950898 | 000 |
| 00858775006198 | K950898 | 000 |
| 00858775006266 | K950898 | 000 |
| 00858775006099 | K950898 | 000 |