The following data is part of a premarket notification filed by Industrial & Medical Design, Inc. with the FDA for Aspiration Pump, Model Imd-020.
| Device ID | K041405 |
| 510k Number | K041405 |
| Device Name: | ASPIRATION PUMP, MODEL IMD-020 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | INDUSTRIAL & MEDICAL DESIGN, INC. 2570 CORPORATE PL., SUITE E104 Monterey Park, CA 91754 |
| Contact | Yevgeniy Kuklin |
| Correspondent | Yevgeniy Kuklin INDUSTRIAL & MEDICAL DESIGN, INC. 2570 CORPORATE PL., SUITE E104 Monterey Park, CA 91754 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-26 |
| Decision Date | 2004-09-02 |
| Summary: | summary |