The following data is part of a premarket notification filed by Milestone Scientific, Inc. with the FDA for Compuflo.
| Device ID | K053554 |
| 510k Number | K053554 |
| Device Name: | COMPUFLO |
| Classification | Pump, Infusion |
| Applicant | MILESTONE SCIENTIFIC, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Howard Holstein |
| Correspondent | Howard Holstein MILESTONE SCIENTIFIC, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-20 |
| Decision Date | 2006-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20618874000220 | K053554 | 000 |
| 00618874116019 | K053554 | 000 |
| 00618874999995 | K053554 | 000 |
| 00618874999988 | K053554 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COMPUFLO 87033377 5643912 Live/Registered |
Milestone Scientific, Inc. 2016-05-11 |
![]() COMPUFLO 77080587 3718973 Live/Registered |
Milestone Scientific, Inc. 2007-01-11 |
![]() COMPUFLO 76261354 not registered Dead/Abandoned |
Milestone Scientific, Inc. 2001-05-23 |
![]() COMPUFLO 75102559 2148609 Dead/Cancelled |
FLOWTRONEX PSI, LTD. 1996-05-10 |
![]() COMPUFLO 74628665 1944185 Dead/Cancelled |
VECTOR CORPORATION 1995-02-02 |
![]() COMPUFLO 73654320 1470182 Dead/Cancelled |
COMPUFLO INC. 1987-04-10 |