K993668 is an FDA 510(k) clearance for the LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20, a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), submitted by Laerdal Medical A/S (Stavanger, NO). The FDA issued a Cleared decision on December 20, 1999, 49 days after receiving the submission on November 1, 1999. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K993668 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 1999 |
| Decision Date | December 20, 1999 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | BTA — Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4780 |