The following data is part of a premarket notification filed by Milestone Scientific, Inc. with the FDA for Compudent Sta.
| Device ID | K061904 |
| 510k Number | K061904 |
| Device Name: | COMPUDENT STA |
| Classification | Syringe, Cartridge |
| Applicant | MILESTONE SCIENTIFIC, INC. 5335 WISCONSIN AVE NW SUITE 440 Washington, DC 20015 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli MILESTONE SCIENTIFIC, INC. 5335 WISCONSIN AVE NW SUITE 440 Washington, DC 20015 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-05 |
| Decision Date | 2006-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00618874000011 | K061904 | 000 |
| 00618874112035 | K061904 | 000 |
| 10618874000025 | K061904 | 000 |
| 10618874000032 | K061904 | 000 |
| 10618874000049 | K061904 | 000 |
| 10618874000056 | K061904 | 000 |
| 20618874000015 | K061904 | 000 |
| 20618874000022 | K061904 | 000 |
| 20618874000039 | K061904 | 000 |
| 20618874000046 | K061904 | 000 |
| 20618874000053 | K061904 | 000 |
| 00618874112042 | K061904 | 000 |