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 |