The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Ambu Twin Pump - (manual Suction Pump).
| Device ID | K883433 |
| 510k Number | K883433 |
| Device Name: | AMBU TWIN PUMP - (MANUAL SUCTION PUMP) |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | AMBU, INC. 7476 NEW RIDGE RD-STE D Hanover, MD 21076 |
| Contact | Frank Homa |
| Correspondent | Frank Homa AMBU, INC. 7476 NEW RIDGE RD-STE D Hanover, MD 21076 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1988-09-02 |