The following data is part of a premarket notification filed by Laerdal Medical A/s with the FDA for Laerdal Suction Unit,(4000) Model 78 00 20.
| Device ID | K993668 |
| 510k Number | K993668 |
| Device Name: | LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | LAERDAL MEDICAL A/S TANKE SVILANDSGT. 30 Stavanger, NO N 4001 |
| Contact | Magne Steinset |
| Correspondent | Magne Steinset LAERDAL MEDICAL A/S TANKE SVILANDSGT. 30 Stavanger, NO N 4001 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-01 |
| Decision Date | 1999-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07045432030839 | K993668 | 000 |
| 07045432030822 | K993668 | 000 |
| 07045430042094 | K993668 | 000 |
| 07045430042087 | K993668 | 000 |