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 |