The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for Genadyne A4 Powered Suction Pump.
| Device ID | K080745 |
| 510k Number | K080745 |
| Device Name: | GENADYNE A4 POWERED SUCTION PUMP |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | GENADYNE BIOTECHNOLOGIES, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | John Pappan |
| Correspondent | John Pappan GENADYNE BIOTECHNOLOGIES, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-17 |
| Decision Date | 2008-07-30 |
| Summary: | summary |