K983552 is an FDA 510(k) clearance for the BASIC, MEDIAN, DOMINANT, AND VARIO. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Medela, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1999, 90 days after receiving the submission on October 9, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K983552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 1998 |
| Decision Date | January 07, 1999 |
| Days to Decision | 90 days |
| Submission Type | Abbreviated |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | BTA — Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |